MedAccred09.22.16
Medmarc, a leading medical device industry insurer specializing in product liability risks facing medical technology and life science companies, has outlined how it believes programs like MedAccred’s critical process supply chain accreditation system are helping the medical device industry to establish, according to Medmarc, “better supplier controls” which “could, over the long term, result in fewer recalls, fewer adverse events, and overall greater quality of products for the industry as a whole.”
From the perspective of a liability insurer, the introduction of a robust critical process accreditation program brings multiple benefits. In Medmarc’s view, “an OEM that maintains firm control over its supply chain can do a lot to mitigate products liability risk.” As a routine part of the underwriting process insurers evaluate the potential risks posed by companies seeking to obtain insurance but it is much more challenging and almost impossible for the insurer to fully assess the risks posed by the supply chain of their potential customer. In an effort to mitigate this risk, the insurer will verify the purchasing controls and supplier qualification procedures of the OEM but often this information can be limited. This is where an accreditation program such as MedAccred can help. Medmarc believes that “a program like MedAccred may provide a measure of confidence in a supply chain that would otherwise be difficult, if not impossible, to obtain through the usual course of underwriting.”
What this translates to in real terms for Medmarc’s customers is summed up in this official statement released by Medmarc, “Medmarc recognizes the value of a supply chain accreditation program, such as MedAccred, and considers the integrity of an applicant’s supplier controls as part of the underwriting process.”
Increasingly, MedAccred is being seen as an opportunity for OEMs to advance to the next level in supply chain risk management. The program represents a systematic tightening of controls which is providing confidence not only internally within the participating OEMs but also externally to their insurance carriers and other interested parties.
Steve Niedelman, lead quality system and compliance consultant from the law firm King & Spalding LLP said, “By assuring the most critical processes are being robustly audited on a regular basis by Subject Matter Experts, and any findings requiring corrective actions are completed prior to accreditation, MedAccred provides greater confidence to the OEM in the quality of what is being outsourced, with a higher expectation that the product will consistently meet design specifications which would likely result in reduced product related complaints and injuries.”
To date, Medmarc has been collaborating with MedAccred to educate medical device companies on the importance of supply chain controls. In the future Medmarc is committed to “continue to provide the industry with information about the importance of supply chain oversight and the positive impact that it can have on the creation of safe products.”
From the perspective of a liability insurer, the introduction of a robust critical process accreditation program brings multiple benefits. In Medmarc’s view, “an OEM that maintains firm control over its supply chain can do a lot to mitigate products liability risk.” As a routine part of the underwriting process insurers evaluate the potential risks posed by companies seeking to obtain insurance but it is much more challenging and almost impossible for the insurer to fully assess the risks posed by the supply chain of their potential customer. In an effort to mitigate this risk, the insurer will verify the purchasing controls and supplier qualification procedures of the OEM but often this information can be limited. This is where an accreditation program such as MedAccred can help. Medmarc believes that “a program like MedAccred may provide a measure of confidence in a supply chain that would otherwise be difficult, if not impossible, to obtain through the usual course of underwriting.”
What this translates to in real terms for Medmarc’s customers is summed up in this official statement released by Medmarc, “Medmarc recognizes the value of a supply chain accreditation program, such as MedAccred, and considers the integrity of an applicant’s supplier controls as part of the underwriting process.”
Increasingly, MedAccred is being seen as an opportunity for OEMs to advance to the next level in supply chain risk management. The program represents a systematic tightening of controls which is providing confidence not only internally within the participating OEMs but also externally to their insurance carriers and other interested parties.
Steve Niedelman, lead quality system and compliance consultant from the law firm King & Spalding LLP said, “By assuring the most critical processes are being robustly audited on a regular basis by Subject Matter Experts, and any findings requiring corrective actions are completed prior to accreditation, MedAccred provides greater confidence to the OEM in the quality of what is being outsourced, with a higher expectation that the product will consistently meet design specifications which would likely result in reduced product related complaints and injuries.”
To date, Medmarc has been collaborating with MedAccred to educate medical device companies on the importance of supply chain controls. In the future Medmarc is committed to “continue to provide the industry with information about the importance of supply chain oversight and the positive impact that it can have on the creation of safe products.”
