Ranica Arrowsmith, Associate Editor10.14.15
“Why then, can one desire too much of a good thing?” — William Shakespeare, “As You Like It.”
There is no escaping the quality discussion. It permeates thinking about medical device development from start to finish. Without it, a device doesn’t get approved; without it, patients’ lives are at risk.
During the 2015 MPO Summit, which wrapped up in Park City, Utah, on Sept. 30, speakers turned their attention to the quality question often. For instance, Linda Braddon, Ph.D., president of Secure BioMed Evaluations, a Woodstock, Ga.-based regulatory support company for medtech companies, stressed the importance of quality for companies not only hoping to get their devices to market fast, but also hoping to be acquired. (Editor’s note: For details on Braddon’s product commercialization and corporate acquisition strategies, please turn to Medtech Musings on page 82).
“Make sure you have the right quality system,” Braddon said. “Make sure your design records actually reflect what you have gotten clearance for.”
Braddon also discussed the importance of continuously modifying and updating a quality system. Improvement is not necessarily key, but use and utility. “If you’re not changing it, you’re not using it.”
The idea of nonstatic quality systems may seem counter-intuitive. After all, perfection in device manufacturing—or in any manufacturing—comes from shaping a system and a supply chain that is reliable, validated and reproducible. But quality assurance can be viewed as a support to device manufacture. It is company-specific, and while it has definite outcome goals (making sure a device is regulatory compliant), a quality system’s actual structure is customizable to a company. Companies also regularly seek to not just meet, but exceed regulatory expectations.
During AdvaMed 2015, held Oct. 5-7 in San Diego, Calif., a panel convened to discuss “the case for quality.” Jeff Fecho, vice president of global quality for St. Paul, Minn.-based St. Jude Medical Inc., said, “We are transitioning from a compliance world to a quality inclusive world.”
This idea summarizes the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health’s (CDRH) Case for Quality initiative, which was launched in 2011. According to the agency, historically, the FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. The focus on quality goes beyond this model by treating compliance only as a baseline. The FDA and stakeholders focus instead on critical-to-quality practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. The FDA is working with stakeholders to promote manufacturers’ implementation of critical-to-quality practices, and it also is looking for ways to account for these practices in its own actions, including possibly streamlining inspections when quality practices are present.
The FDA’s review of data before launching Case for Quality in 2011 yielded a simple idea: investing in quality pays. The agency’s analysis flagged manufacturing quality risks and showed that firms that manage those risks by driving quality organization-wide are more productive, with fewer complaints and investigations per batch, and often with smaller quality units with lower quality-related costs than their competitors.
The initiative’s core components are three-fold: Focus on quality, enhance data transparency and engage stakeholders.
Historically, the FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. The focus on quality goes beyond this model by treating compliance only as a baseline. The FDA and stakeholders focus instead on critical-to-quality practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes.
As part of the focus on quality, the FDA is launching a pilot that establishes a collaborative framework for determining specific operations, design considerations, and controls that impact the quality and safety of implantable devices that use batteries. The FDA will develop an inspection-driven approach that focuses on those specific operations, design considerations, and controls and the participants will collaborate on outcome measures to evaluate the effectiveness of this revised approach.
The FDA receives a broad array of quality-related data, including information from recall and adverse event reports and inspection results. The agency proposes to leverage this data through multiple strategies that support device quality. For example, to enhance independent analyses by stakeholders, FDA officials are exploring publishing their data so that it can automatically be accessed and searched by external analytical tools. They also are conducting and publishing analyses of these data, which will draw from the agency’s recall data as well as inspectional observations and warning letters.
As for engaging stakeholders—since the Case for Quality launched, FDA staff has met with stakeholders regularly, including at meetings such as AdvaMed, to present the ideas and solicit feedback.
When Quality is Not Just About Quality
There also are misconceptions that companies must dispel when creating and maintaining quality systems. Here’s where it gets interesting. While Braddon stresses that under-preparation is anathema, over-preparation of a quality system is also a pitfall to be avoided.
“Never underestimate what it takes to establish a quality system,” Braddon said. “If you think, ‘we can throw something together while waiting for FDA to respond to a 510(k) submission,’ you’re wrong. If you think, ‘anyone can implement a quality system,’ you’re wrong. But at the same time, don’t overestimate what you need to do. That thinking of, ‘we need everything covered because we live in a litigious society’ is paralyzing.”
The term “quality” evokes the idea of standards, performance, durability and compliance. But it also is a concrete part of a medical device supply chain—one that should help, not hinder, companies achieve profitability and speed to market. While all medical device manufacturers are making products that ultimately will impact patient lives, they also have other concerns, such as profit and speed to market.
According to Braddon, a good quality plan is one of a company’s “best tools” in the early stages of attempting to get a product to market, but not a tool that has to be fully forged and solidified. As mentioned earlier, quality plans and systems are by nature fluid and evolutionary.
“Having ‘just enough’ of a quality system and a really, really good regulatory plan is key,” she said at the MPO Summit. “You’ll likely not need a fully birthed quality system for CE mark or commercialization requirements. So don’t spend too much time on that early on.”
When the perfect is the enemy of the good, companies can get bogged down in creating “perfect” quality systems before they have to.
Quality Roundtable
Medical Product Outsourcing convened a group of industry experts to weigh in on key quality questions. Contributors included:
Linda Braddon, Ph.D.
Michael Faulkner, president of Gardner, Mass.-based Biomedical Polymers (BMP), which manufactures plastic consumables for research and medical diagnostic laboratories.
Alan Schwartz, executive vice president at Great Neck, N.Y.-based MDI Consultants Inc., which provides consulting services to the healthcare industry globally.
Mohan Ponnudurai, industry solutions director at Sparta Systems Inc., a Hamilton, N.J.-based provider of enterprise quality management software solutions.
MPO: How do you maintain strict quality control all along the medical device supply chain, specifically avoiding human error and ensuring compliance from every person involved in the chain?
Linda Braddon: The best way to maintain quality control is to make sure you have a good internal audit process. This is a commonly overlooked activity but critical. It is impossible to avoid human error. The best way to catch these errors is to have a fresh set of eyes on the documentation during the quality review. By adequately defining your process, quality inspections, and associated documentation in your quality system, you can minimize human error. Ongoing training is also important. You also want to make sure that your trainers are training to the procedure and not just training based on how the previous person performed the task.
Michael Faulkner: One of the biggest challenges BMP faces as an OEM supplier is avoiding human error. An example of risk mitigation BMP has adopted in the past year was introducing an automated vision system in our QC laboratory. This vision system allows any operator to accurately measure parts with pre-programmed acceptance criteria and statistical analysis. Not only has this system mitigated any possibility of human error, it has increased the efficiency of the lab by allowing for multiple measurements to be taken at one time.
Alan Schwartz: Maintaining strict QC along the supply chains is a very difficult task, especially avoiding human errors and maintaining compliance. First of all, you need a written agreement between your vendors (suppliers) and you as to their responsibilities and the company’s. Next you need to audit the vendor on a routine basis. Depending on the critical nature (risk assessment) of the component being supplied, the number of times requiring auditing would be set up. If you are able to go to a Dock to Stock supplier, you need to have a procedure in place on how a supplier can achieve this level of approval and then strictly follow those procedures. If you find a problem with the components, you need to know how your supplier will handle your complaints and implement their investigations and CAPAs (corrective and preventive actions). The only way to assure that your suppliers will provide you the level of quality you expect is to be on top of them and monitor their progress and non-conformances both with the product and documentation.
Mohan Ponnudurai: What we are seeing in the industry is that the supply chain is more global, including dispersed CMOs (contract manufacturing organizations), component supplies and even country-specific outsourced packaging. What this means is keeping tabs on those third-party stakeholders is even more important and critical. Having those stakeholders direct entry to compliance-related solutions without infringing on data security is an essential strategy, not only for compliance but also to resolve issues quicker and effectively. This allows us to reduce human error through redundant data entry, and the possibility of not entering the right issues, thus dropping the issue totally, resulting in downstream issues leading to wrong parts, wrong materials, wrong processes or wrong packaging going to the market and worse, recalls. This requires technology investments which are more readily available today than in the past.
MPO: What are your top concerns regarding quality of medical devices in the current climate of the medtech industry?
Braddon: Quality efforts can be hampered financially by the current state of the economy and the cost of taxes and regulatory burden on the medical device industry. Additionally, the pool of experienced and knowledgeable quality professionals does not seem to be sufficient to meet the needs of industry. Also, the quality of a device can be affected by a company wanting to rush to market. Specifically, a variety of controls are often overlooked with the pressure of meeting a deadline for initial launch.
Faulkner: As many U.S.A.-based medical device companies do, BMP relies on offshore manufacturing for a small portion of our manufacturing supply chain. There is inherent risk by manufacturing off shore. Lead time, quality, and reaction to quality issues are some examples of those risks. Three years ago, BMP had the opportunity to repatriate an overseas manufacturing line back to the U.S. Not only were we able to bring the job back to the domestic arena, we were able to add efficiency to the manufacturing process and significantly increase the level of quality for the product line.
Schwartz: The main concern of any medical device is based on the risk assessment of the device and potential failures. You want to make sure that your development work takes into account all potential failures and try to design the failures out or back up systems, and if that does not work then the correct labeling and warnings. Most problems associated with today’s devices are related to user error. Doing human factor studies is one way of evaluating if your device design can meet your users’ expectations.
Ponnudurai: Not having effective supplier control is one of the top three causes of 483s (warning letters) and recalls. You have full visibility and control of all quality processes within your four walls, but outside of them is not. This is the biggest challenge and concern.
MPO: Can you discuss a recent quality-related challenge you/your company had to face, and how it was overcome?
Braddon: We deal with lots of quality-related challenges due to the nature of our business model. The most impactful quality challenges are usually surrounding the process/device validations that need to occur prior to initial commercial release. For example, design changes after design verification/validation testing may trigger all new testing to confirm a new round of testing, including long lead time activities such as a sterilization validation. This is often a hard pill to swallow for someone new to the industry and eager to achieve sales.
Faulkner: One of BMP’s largest OEM customers has a medical device that poses some very difficult manufacturing challenges. The design of the device has a very thin wall section, and maintaining the integrity of that wall during the molding process requires very precise molding parameters. To reach and maintain those tight tolerances, BMP introduced an internal automated sensor system that monitors and analyzes several of the molding parameters on each shot. The system then uses that data to determine if all of the criteria have been met, and if the parts are acceptable. In addition to the sensors, we have also introduced an in-line vacuum testing system to the end of arm tooling as a QC (quality control) measure to detect any possible defect in the wall of the part. Since BMP introduced these measures, we have virtually eliminated our scrap rate and exceeded our customer’s expectations.
Ponnudurai: FDA audits are always challenging, and having access to appropriate information (not data) readily available for the auditor is crucial for a successful audit. This is even more troublesome when there had been prior issues, and to provide evidence of successfully resolving or eradicating the root cause means you need to have the right set of evidentiary data. This can be in the form of trends, queries, charts and other supporting record level information.
MPO: If you could wave a magic wand, how would you change current QA/RA approaches across the board in medtech?
Braddon: More QA/RA (quality assurance/regulatory affairs) involvement early in the development process. While there may be a tendency of some QA/RA professionals to prematurely implement QMS (quality management system) requirements during development—and this should be avoided—involvement of the right level of QA/RA feedback early in the process ensures a more timely path to market.
Schwartz: A magic wand—I’m not sure there is something like a magic wand especially when it comes to dealing with humans. There are too many variables. The best that could be hoped for is true consciousness by company management and commitment to give the time, effort, training and backing to the company staff to make sure that quality is the main concern.
Ponnudurai: There are so many global variations for the same requirements; look at UDI (unique device identification), or product registration, or eMDR (electronic medical device reporting) or even regulatory audits. It would be so much easier, faster and more efficient if there was a single type of requirement that the global authorities can share. This will ease the resource and technology demand for both the vendors and authorities.
MPO: How are regulatory requirements affecting QA/RA approaches at your company?
Braddon: Clearly, regulatory requirements drive the QA/RA approaches. Regulatory requirements are a moving target and not always consistent across either different groups within FDA or even notified body approaches. In regards to product clearances or CE marking, it is critical to maintain an open line of communication with the reviewing agency to understand differences in their approach, which may affect how we do our job.
Schwartz: The problem with the regulatory requirements is not the requirements but more how the regulatory agencies enforce the requirements. If you look at the regulatory requirements from our experience they are of real value, the QSR/cGMPs (quality systems regulation/current good manufacturing practice) if they are implemented properly and maintained. The problem arises when you have to deal with the regulatory agency and interpret actions concerning compliance. Dealing with the regulations can be difficult at times, especially when involved with high-risk medical devices.
There is no escaping the quality discussion. It permeates thinking about medical device development from start to finish. Without it, a device doesn’t get approved; without it, patients’ lives are at risk.
During the 2015 MPO Summit, which wrapped up in Park City, Utah, on Sept. 30, speakers turned their attention to the quality question often. For instance, Linda Braddon, Ph.D., president of Secure BioMed Evaluations, a Woodstock, Ga.-based regulatory support company for medtech companies, stressed the importance of quality for companies not only hoping to get their devices to market fast, but also hoping to be acquired. (Editor’s note: For details on Braddon’s product commercialization and corporate acquisition strategies, please turn to Medtech Musings on page 82).
“Make sure you have the right quality system,” Braddon said. “Make sure your design records actually reflect what you have gotten clearance for.”
Braddon also discussed the importance of continuously modifying and updating a quality system. Improvement is not necessarily key, but use and utility. “If you’re not changing it, you’re not using it.”
The idea of nonstatic quality systems may seem counter-intuitive. After all, perfection in device manufacturing—or in any manufacturing—comes from shaping a system and a supply chain that is reliable, validated and reproducible. But quality assurance can be viewed as a support to device manufacture. It is company-specific, and while it has definite outcome goals (making sure a device is regulatory compliant), a quality system’s actual structure is customizable to a company. Companies also regularly seek to not just meet, but exceed regulatory expectations.
During AdvaMed 2015, held Oct. 5-7 in San Diego, Calif., a panel convened to discuss “the case for quality.” Jeff Fecho, vice president of global quality for St. Paul, Minn.-based St. Jude Medical Inc., said, “We are transitioning from a compliance world to a quality inclusive world.”
This idea summarizes the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health’s (CDRH) Case for Quality initiative, which was launched in 2011. According to the agency, historically, the FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. The focus on quality goes beyond this model by treating compliance only as a baseline. The FDA and stakeholders focus instead on critical-to-quality practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. The FDA is working with stakeholders to promote manufacturers’ implementation of critical-to-quality practices, and it also is looking for ways to account for these practices in its own actions, including possibly streamlining inspections when quality practices are present.
The FDA’s review of data before launching Case for Quality in 2011 yielded a simple idea: investing in quality pays. The agency’s analysis flagged manufacturing quality risks and showed that firms that manage those risks by driving quality organization-wide are more productive, with fewer complaints and investigations per batch, and often with smaller quality units with lower quality-related costs than their competitors.
The initiative’s core components are three-fold: Focus on quality, enhance data transparency and engage stakeholders.
Historically, the FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. The focus on quality goes beyond this model by treating compliance only as a baseline. The FDA and stakeholders focus instead on critical-to-quality practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes.
As part of the focus on quality, the FDA is launching a pilot that establishes a collaborative framework for determining specific operations, design considerations, and controls that impact the quality and safety of implantable devices that use batteries. The FDA will develop an inspection-driven approach that focuses on those specific operations, design considerations, and controls and the participants will collaborate on outcome measures to evaluate the effectiveness of this revised approach.
The FDA receives a broad array of quality-related data, including information from recall and adverse event reports and inspection results. The agency proposes to leverage this data through multiple strategies that support device quality. For example, to enhance independent analyses by stakeholders, FDA officials are exploring publishing their data so that it can automatically be accessed and searched by external analytical tools. They also are conducting and publishing analyses of these data, which will draw from the agency’s recall data as well as inspectional observations and warning letters.
As for engaging stakeholders—since the Case for Quality launched, FDA staff has met with stakeholders regularly, including at meetings such as AdvaMed, to present the ideas and solicit feedback.
When Quality is Not Just About Quality
There also are misconceptions that companies must dispel when creating and maintaining quality systems. Here’s where it gets interesting. While Braddon stresses that under-preparation is anathema, over-preparation of a quality system is also a pitfall to be avoided.
“Never underestimate what it takes to establish a quality system,” Braddon said. “If you think, ‘we can throw something together while waiting for FDA to respond to a 510(k) submission,’ you’re wrong. If you think, ‘anyone can implement a quality system,’ you’re wrong. But at the same time, don’t overestimate what you need to do. That thinking of, ‘we need everything covered because we live in a litigious society’ is paralyzing.”
The term “quality” evokes the idea of standards, performance, durability and compliance. But it also is a concrete part of a medical device supply chain—one that should help, not hinder, companies achieve profitability and speed to market. While all medical device manufacturers are making products that ultimately will impact patient lives, they also have other concerns, such as profit and speed to market.
According to Braddon, a good quality plan is one of a company’s “best tools” in the early stages of attempting to get a product to market, but not a tool that has to be fully forged and solidified. As mentioned earlier, quality plans and systems are by nature fluid and evolutionary.
“Having ‘just enough’ of a quality system and a really, really good regulatory plan is key,” she said at the MPO Summit. “You’ll likely not need a fully birthed quality system for CE mark or commercialization requirements. So don’t spend too much time on that early on.”
When the perfect is the enemy of the good, companies can get bogged down in creating “perfect” quality systems before they have to.
Quality Roundtable
Medical Product Outsourcing convened a group of industry experts to weigh in on key quality questions. Contributors included:
Linda Braddon, Ph.D.
Michael Faulkner, president of Gardner, Mass.-based Biomedical Polymers (BMP), which manufactures plastic consumables for research and medical diagnostic laboratories.
Alan Schwartz, executive vice president at Great Neck, N.Y.-based MDI Consultants Inc., which provides consulting services to the healthcare industry globally.
Mohan Ponnudurai, industry solutions director at Sparta Systems Inc., a Hamilton, N.J.-based provider of enterprise quality management software solutions.
MPO: How do you maintain strict quality control all along the medical device supply chain, specifically avoiding human error and ensuring compliance from every person involved in the chain?
Linda Braddon: The best way to maintain quality control is to make sure you have a good internal audit process. This is a commonly overlooked activity but critical. It is impossible to avoid human error. The best way to catch these errors is to have a fresh set of eyes on the documentation during the quality review. By adequately defining your process, quality inspections, and associated documentation in your quality system, you can minimize human error. Ongoing training is also important. You also want to make sure that your trainers are training to the procedure and not just training based on how the previous person performed the task.
Michael Faulkner: One of the biggest challenges BMP faces as an OEM supplier is avoiding human error. An example of risk mitigation BMP has adopted in the past year was introducing an automated vision system in our QC laboratory. This vision system allows any operator to accurately measure parts with pre-programmed acceptance criteria and statistical analysis. Not only has this system mitigated any possibility of human error, it has increased the efficiency of the lab by allowing for multiple measurements to be taken at one time.
Alan Schwartz: Maintaining strict QC along the supply chains is a very difficult task, especially avoiding human errors and maintaining compliance. First of all, you need a written agreement between your vendors (suppliers) and you as to their responsibilities and the company’s. Next you need to audit the vendor on a routine basis. Depending on the critical nature (risk assessment) of the component being supplied, the number of times requiring auditing would be set up. If you are able to go to a Dock to Stock supplier, you need to have a procedure in place on how a supplier can achieve this level of approval and then strictly follow those procedures. If you find a problem with the components, you need to know how your supplier will handle your complaints and implement their investigations and CAPAs (corrective and preventive actions). The only way to assure that your suppliers will provide you the level of quality you expect is to be on top of them and monitor their progress and non-conformances both with the product and documentation.
Mohan Ponnudurai: What we are seeing in the industry is that the supply chain is more global, including dispersed CMOs (contract manufacturing organizations), component supplies and even country-specific outsourced packaging. What this means is keeping tabs on those third-party stakeholders is even more important and critical. Having those stakeholders direct entry to compliance-related solutions without infringing on data security is an essential strategy, not only for compliance but also to resolve issues quicker and effectively. This allows us to reduce human error through redundant data entry, and the possibility of not entering the right issues, thus dropping the issue totally, resulting in downstream issues leading to wrong parts, wrong materials, wrong processes or wrong packaging going to the market and worse, recalls. This requires technology investments which are more readily available today than in the past.
MPO: What are your top concerns regarding quality of medical devices in the current climate of the medtech industry?
Braddon: Quality efforts can be hampered financially by the current state of the economy and the cost of taxes and regulatory burden on the medical device industry. Additionally, the pool of experienced and knowledgeable quality professionals does not seem to be sufficient to meet the needs of industry. Also, the quality of a device can be affected by a company wanting to rush to market. Specifically, a variety of controls are often overlooked with the pressure of meeting a deadline for initial launch.
Faulkner: As many U.S.A.-based medical device companies do, BMP relies on offshore manufacturing for a small portion of our manufacturing supply chain. There is inherent risk by manufacturing off shore. Lead time, quality, and reaction to quality issues are some examples of those risks. Three years ago, BMP had the opportunity to repatriate an overseas manufacturing line back to the U.S. Not only were we able to bring the job back to the domestic arena, we were able to add efficiency to the manufacturing process and significantly increase the level of quality for the product line.
Schwartz: The main concern of any medical device is based on the risk assessment of the device and potential failures. You want to make sure that your development work takes into account all potential failures and try to design the failures out or back up systems, and if that does not work then the correct labeling and warnings. Most problems associated with today’s devices are related to user error. Doing human factor studies is one way of evaluating if your device design can meet your users’ expectations.
Ponnudurai: Not having effective supplier control is one of the top three causes of 483s (warning letters) and recalls. You have full visibility and control of all quality processes within your four walls, but outside of them is not. This is the biggest challenge and concern.
MPO: Can you discuss a recent quality-related challenge you/your company had to face, and how it was overcome?
Braddon: We deal with lots of quality-related challenges due to the nature of our business model. The most impactful quality challenges are usually surrounding the process/device validations that need to occur prior to initial commercial release. For example, design changes after design verification/validation testing may trigger all new testing to confirm a new round of testing, including long lead time activities such as a sterilization validation. This is often a hard pill to swallow for someone new to the industry and eager to achieve sales.
Faulkner: One of BMP’s largest OEM customers has a medical device that poses some very difficult manufacturing challenges. The design of the device has a very thin wall section, and maintaining the integrity of that wall during the molding process requires very precise molding parameters. To reach and maintain those tight tolerances, BMP introduced an internal automated sensor system that monitors and analyzes several of the molding parameters on each shot. The system then uses that data to determine if all of the criteria have been met, and if the parts are acceptable. In addition to the sensors, we have also introduced an in-line vacuum testing system to the end of arm tooling as a QC (quality control) measure to detect any possible defect in the wall of the part. Since BMP introduced these measures, we have virtually eliminated our scrap rate and exceeded our customer’s expectations.
Ponnudurai: FDA audits are always challenging, and having access to appropriate information (not data) readily available for the auditor is crucial for a successful audit. This is even more troublesome when there had been prior issues, and to provide evidence of successfully resolving or eradicating the root cause means you need to have the right set of evidentiary data. This can be in the form of trends, queries, charts and other supporting record level information.
MPO: If you could wave a magic wand, how would you change current QA/RA approaches across the board in medtech?
Braddon: More QA/RA (quality assurance/regulatory affairs) involvement early in the development process. While there may be a tendency of some QA/RA professionals to prematurely implement QMS (quality management system) requirements during development—and this should be avoided—involvement of the right level of QA/RA feedback early in the process ensures a more timely path to market.
Schwartz: A magic wand—I’m not sure there is something like a magic wand especially when it comes to dealing with humans. There are too many variables. The best that could be hoped for is true consciousness by company management and commitment to give the time, effort, training and backing to the company staff to make sure that quality is the main concern.
Ponnudurai: There are so many global variations for the same requirements; look at UDI (unique device identification), or product registration, or eMDR (electronic medical device reporting) or even regulatory audits. It would be so much easier, faster and more efficient if there was a single type of requirement that the global authorities can share. This will ease the resource and technology demand for both the vendors and authorities.
MPO: How are regulatory requirements affecting QA/RA approaches at your company?
Braddon: Clearly, regulatory requirements drive the QA/RA approaches. Regulatory requirements are a moving target and not always consistent across either different groups within FDA or even notified body approaches. In regards to product clearances or CE marking, it is critical to maintain an open line of communication with the reviewing agency to understand differences in their approach, which may affect how we do our job.
Schwartz: The problem with the regulatory requirements is not the requirements but more how the regulatory agencies enforce the requirements. If you look at the regulatory requirements from our experience they are of real value, the QSR/cGMPs (quality systems regulation/current good manufacturing practice) if they are implemented properly and maintained. The problem arises when you have to deal with the regulatory agency and interpret actions concerning compliance. Dealing with the regulations can be difficult at times, especially when involved with high-risk medical devices.