Regulatory & Compliance Perspectives

1. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

2. EC Rep To EU Rep: The Symbol Shift You Can't Ignore 4/23/2025

   The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.”

3. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

4. Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K. 3/26/2025

   Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.

5. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

   Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.

    

6. Mastering FDA Inspections: The Prep Work For Regulatory Success 2/21/2025

   In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product quality, operational efficiency, and patient safety. Shift from a reactive to a proactive mindset.

7. Telehealth In 2025 And Beyond: The Future Is Bright 2/14/2025

   The DEA has announced new rules for remote prescription of controlled substances. As telehealth adoption grows, regulatory frameworks and telehealth technologies are evolving.

8. Roche Diagnostics Guides New Alzheimer's Test Through Trials 2/12/2025

   Roche Diagnostics’ Maria-Magdelena Patru, MD, PhD discusses their plasma test and how they’re approaching its clinical trials. 

9. PMS And Supply Chain Visibility For EU Compliance 2/10/2025

   One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.

10. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.