February 2023 Medical Device and IVD News Update

February 15, 2023

This month we'll look at key FDA policies, procedures, and practices before, during and after inspections, provide tips for writing effective nonconformity statements during QMS audits, and more.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections

Understanding the FDA policies, procedures and practices that shape your FDA inspection should help you understand what to expect prior to, during and after your next inspection. Read our whitepaper by Robert Ruff, Executive Director at NSF and ex-FDA field investigator and CDRH compliance officer for a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.

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Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

For medical device quality management system auditors, effectively communicating nonconformities to the auditee organization is essential. Without clearly written nonconformity statements, the potential for an auditee organization to misunderstand the nonconformity increases. This can lead to difficulty investigating the nonconformity and, in turn, difficulty implementing necessary containment, corrections, corrective actions and systemic corrective actions. However, it is possible to write effective nonconformity statements that are easy to read and easy to understand. In this informative paper, we have compiled a few simple tools and tips to help you consistently create clear, concise, and precise nonconformity statements.

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Events Update

It’s been great to be at Arab Health and MD&M West in the last few weeks. Don’t worry if you missed us, contact us to book a call with our MedTech regulatory experts to find out how we can help you with auditing, consulting, and training services. We offer:

QMS & Compliance Support
GMP/Readiness Audits & Mock Inspections
Global Regulatory Affairs
Enforcement Support & Remediation
Training & Education Solutions

Contact us

Save the Date for Our 12th Medical Devices Symposium

Join industry experts for an engaging discussion on MDR transition periods, how to get competitive and sustainable medical devices to market, and more!

September 14-15 2023 | Hamburg

Booking open soon!

Spotlight on Training

Understanding Top Management Responsibilities for Medical Device Quality Management Systems

This course is designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016. This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.

Medical Device Regulatory Requirements: Five-Course MDSAP Bundle

This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.

MDSAP Countries include: Australia, Brazil, Canada, Japan and the United States. (Each of the five courses can also be purchased individually.)

Learn what it takes to bring a product to market in each MDSAP-participating country and keep it there. We introduce the Medical Device Single Audit Program (MDSAP) and cover pre- and post-market requirements, and explain how each country utilizes MDSAP in its regulatory framework.

Our global medical device experts ensure content is up to date, highly interactive and designed with a visual learner in mind. These courses offer one-of-a-kind training developed by device experts and former regulators from around the globe. We provide English translations of regulations that are very difficult to locate, specifically Brazil and Japan.

Competency assessments provide documented evidence for the training requirements of ISO 13485, the international quality management system standard for medical devices.