February 2023 Medical Device and IVD News Update

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.

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.

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

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

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