Search Results for 'risk management'
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Software & IT
Health Sector Updates Toolkit for Healthcare Supply Chain Cybersecurity Risk Management
Provides actionable guidance and practical methods to help organizations manage their cybersecurity risks.Charles Sternberg, Associate Editor 10.05.23
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Software & IT
Holistic Risk Management: Navigating the Future’s Uncertainties
Let's consider risk from two different angles: predictability and preventability.Fabrizio Maniglio, Director of Industry and Business Development, Sparta Systems, a Honeywell company 09.06.23
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Software & IT
HSCC Publishes Guidance on Cyber Risk Management
The 115-page toolkit recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology.Charles Sternberg, Associate Editor 03.13.23
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R&D & Design
Product End-of-Life Risk Management: Minimizing Liabilities
A priority for medical device companies.Online Exclusives Farida Ali, CEO and President of Dynamic Technology Solutions 06.03.22
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HSCC Publishes Supply Chain Cybersecurity Risk Management Toolkit
Provides guidance and tools to help organizations manage cybersecurity risks.The Healthcare and Public Health Sector Coordinating Council 09.22.20
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Software & IT
Areas to Consider in Medical Device Risk Management
How to ensure the production of safe and effective medical devices.Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 08.24.20
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Surgical | Testing
Medical Robots: Assessing Safety and Performance in a Growing Field
Be aware of potential hazards robots may present and testing options to address them.Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
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COVID-19 is Exposing the Fragility of Global Supply Chains
Pandemic likely will prompt healthcare companies to reshape supply chains to strengthen the risk management process and resilience.GlobalData 04.13.20
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Diagnostics
Gaining a Clearer Picture of Hitachi
Diagnostic imaging is gaining the attention of many in healthcare as the technologies shrink in size and become available to those outside the hospital.Sean Fenske, Editor-in-Chief 04.01.20
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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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R&D & Design
Four Considerations for Developers of Next-Generation Combination Products
Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20
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Materials
A Matter of Substance: Medical Device Materials
Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.Michael Barbella, Managing Editor 03.04.20
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Software & IT
The True Cost of Paper
Rethinking your approach to quality management.Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 02.13.20
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Abbott Labs Executive Joins McKesson as Chief Technology Officer
New hire will be in charge of the company's enterprise business technology strategy.Business Wire 01.30.20
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Software & IT
Six Mistakes to Avoid When Implementing ISO 13485
Ditching the checkbox mentality and last-minute scrambles.Online Exclusives Jon Speer, founder and VP of QA/RA at Greenlight Guru 01.20.20
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5 Tips to Raise Investor Interest and Fund Your Medical Device
Make your startup more attractive to investors.Online Exclusives Jon Speer, Founder of Greenlight Guru 01.15.20
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Software & IT
Days of Future Past: Predictions for MDR Supplier Success
Vertical specialization, quality systems-based production, supplier scale, advanced automation solutions, and entrepreneurial focus are a winning combination.Online Exclusives Marc Miller, Division President, TransPerfect Medical Device Solutions 01.06.20
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Cardiovascular
New Member Joins Cardiovascular Systems Board
Retired Ernst & Young partner is replacing long-serving board member.Business Wire 01.06.20
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EU's MDR: Irresistible Force Meets Immovable Object
EU MDR is colliding with the device industry’s approach & structure to create a perfect storm for manufacturers.Online Exclusives Marc Miller, Transperfect Medical Solutions 12.11.19
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Software & IT
Survey Identifies Challenges to Improving Product Development Processes
81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.PRWeb 11.26.19
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Packaging & Sterilization
Anxious Undertones: The 2019 Year in Review
Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.Michael Barbella, Managing Editor 11.04.19
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Enhanced EQMS Including EU MDR Support Launched by IQVIA MedTech
Company claims first Enterprise Quality Management Solution in the industry with expanded capabilities for EU MDR compliance.Business Wire 10.28.19
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Molding
Mack Molding Promotes Manager to Quality Director
New director has more than three decades of experience in quality and compliance.Mack Molding 10.23.19
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Software & IT
HSCC Publishes Guidance on Cybersecurity Risk Management
Provides actionable guidance and practical tools.HSCC 10.16.19
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Testing
Managing Risks for Medical Devices: A Guide to Understanding ISO 14971
The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19
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Contract Manufacturing | Software & IT
Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing
Industry 4.0 represents the dawn of the digital transformation that began with the third revolution, connecting the physical and natural worlds.Scott Reedy, Senior Director of Marketing, Arena Solutions 10.08.19
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MPO Summit 2019 Conference Program Notebook
An ongoing update of MPO Summit 2019 sessions.Online Exclusives Michael Barbella, Managing Editor 10.03.19
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Digital Health | Software & IT
Nova Leah Achieves ISO 27001 and ISO 9001
Cybersecurity solutions provider for medical device manufacturers was awarded certifications by the NSAI.Nova Leah 09.25.19
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Cardiovascular | Contract Manufacturing | Diagnostics | Digital Health | Electronics | Neurological | Patient Monitoring | R&D & Design
Customized Connections: A Discussion on Custom Electronics
Demand for more complex, traceable, integrated solutions are driving innovation in the fast-changing medical electronics market.Michael Barbella, Managing Editor 09.09.19
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Materials | Testing
Understanding Food-Grade vs. Biocompatibility for Medical Device Materials
Just because a material is food-safe in no way implies it is also biocompatible.Online Exclusives Dana Trousil, Medical NPI Team Lead, StarFish Medical 08.13.19
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Diagnostics | Software & IT
5 Lessons Learned: Avoiding the Quest Data Breach
Quest Diagnostics and LabCorp's recent security breaches stress the importance of taking third-party risk seriously.Online Exclusives Jon Siegler, Chief Product Officer, LogicGate 07.29.19
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Software & IT
Not All Medical Device QMS Solutions Are Created Equal
How to choose a QMS that will set your emerging company up for future success.Online Exclusives Evan Luxon, Co-Founder and CEO of Centese 06.24.19
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Software & IT
Connected Quality Systems Reduce Risks
...Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19
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What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes?
By Edwin L. Bills, Consultant for Qosina
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Contract Manufacturing | Digital Health | Software & IT | Surgical
6 Trends Reshaping Medical Equipment Manufacturing
Medical device manufacturers and end users alike must keep an eye on current industry trends in order to prepare and adapt.Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 05.30.19
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Cardiovascular | Diagnostics | Digital Health | Software & IT
FDA OKs Mobile Phone-Based Heart Murmur Detection Tool
eMurmur ID is an artificial intelligence-based solution that enables healthcare providers to detect and classify heart murmurs with expert-level accuracy.PR Newswire 05.15.19
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Software & IT
Using Digitization to Get Ahead in Medtech
...Bryant Headley, Customer Success Executive, MasterControl 05.01.19
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Contract Manufacturing | Electronics | Molding
Phillips-Medisize Expands FDA Compliant Medical Manufacturing Capacity
Firm recognizes need to support growing customer requirements.Phillips-Medisize 04.24.19
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The Quest for Cake: Leveraging Quality as a Business Partner
The quality function is not only about maintaining compliance; rather, real-world savings can be realized through its adherence.Paul Robinson, Vice President of Operations, Quality Systems Consulting Services (QSCS) 04.03.19
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Software & IT
Five Questions to Improve Your Requirements Management
...Kevin Steigerwald, VP of Product & UX, Jama Software 04.03.19
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Software & IT
Digital Transformation: Seven Considerations for Your QMS
...Tony Parise, Product Strategist—Life Sciences, ETQ 04.03.19
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Mack Molding Appoints Quality Manager Focused on Medical and Regulatory Compliance
New hire brings more than 30 years of experience to the position.Mack Molding 03.19.19
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R&D & Design | Software & IT | Testing
Transformative Testing: Addressing Patient Safety and Cybersecurity
With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.Mark Crawford, Contributing Writer 03.07.19
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Insulet Appoints Venture Fund Executive to its Board of Directors
New member also worked at Edwards Lifesciences for seven years.Business Wire 03.07.19
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Industry Experts Combine to Create Safer Intravenous Delivery
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution.Particle Measuring Systems 03.05.19
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Electronics
East/West Manufacturing Enterprises Earns ISO 13485:2016 Certification
Company also reports 50 percent fourth-quarter 2018 revenue increase.East/West Manufacturing Enterprises 02.15.19
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Electronics
OmniVision Expands Image Signal Processor Family for Endoscopes and Catheters
New OVMed ISPs provide industry with widest range of performance, features, costs for greater design flexibility and rapid integration into medical devices.OmniVision Technologies Inc. 02.05.19
