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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices

Leave a Comment / compliance, Digital Health, Final Guidance, Medical Device, MedTech, off the shelf software, premarket approval, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By

Final Guidance for Submission of Off-The-Shelf Software in Medical Devices     On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation …

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Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

Leave a Comment / compliance, cybersecurity, Digital Health, Focus Article, ISA/IEC 62443, Medical Device, medical device software, MedTech, Product Design & Development, Quality/Regulatory, RC - Device Design & Manufacturing, RTA, SOBM / By

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials     In recent years, more and more medical device manufacturers (MDMs) have come to rely on software bill of materials, or SBOMs. Some do this to help track licensing while others do so as part of a product vulnerability management process. In …

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Automating Computer Systems Validation for Your QMS

Leave a Comment / automation, compliance, computer system validation, CSA, Digital Health, Medical Device, MedTech, quality management, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, Soapbox / By

Automating Computer Systems Validation for Your QMS      Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …

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Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market

Leave a Comment / Asian market, compliance, From The Editor's Desk, Medical Device, MedTech, PSM, Quality/Regulatory, recalls, regulatory intelligence, SLR / By

Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market     The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and …

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Regulating Point of Care Printed Devices

Leave a Comment / 3D printing, compliance, liability, malpractice, Medical Device, MedTech, Product Design & Development, prosthetics, Quality/Regulatory, RC - Quality & Regulatory Market Access Solutions / By

Regulating Point of Care Printed Devices     The use of 3D printing for medical devices opens tremendous opportunities in health care. It allows users to test and adjust components more quickly than traditional manufacturing and enables the creation of personalized products, such as custom prosthetics. However, questions remain about what oversight the FDA will have …

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Risk Management Is More Than a Spreadsheet

Leave a Comment / change management, compliance, Design, FMEA, Manufacturing Execution, Medical Device, MedTech, PLM, Quality/Regulatory, RC - PLM for Medical Devices, risk management, Soapbox / By

Risk Management Is More Than a Spreadsheet     In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …

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RQM+ Appoints Mahofski as Head of Mergers and Acquisitions

Leave a Comment / acquisitions, compliance, Medical Device, Medrad, MedTech, Mergers, Mhofski, Quality/Regulatory, regulatory services / By

RQM+ Appoints Mahofski as Head of Mergers and Acquisitions     Ronnie Mahofski is the new head of mergers and acquisitions (M&A) at RQM+, a global provider of MedTech regulatory and quality experts. Mahofski has more than 20 years of experience in the MedTech industry and has held various positions at RQM+, including overseeing M&A integration …

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Five Most Common Compliance Problems

Leave a Comment / climate change, compliance, cybersecurity, data storage, Focus Article, human error, Medical Device, MedTech, patient privacy, PHI, Quality/Regulatory / By

Five Most Common Compliance Problems     Regulatory compliance in health care is a vital part of patient care. Regulations create frameworks for best practices among different healthcare organizations. But when it comes to compliance protocols, many healthcare organizations are operating suboptimal or inefficient systems. Two of the major issues in this regard are when healthcare …

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