Regulatory & Compliance Perspectives

  1. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

  2. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2 5/13/2025

    This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.

  3. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

    This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

  4. 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.

  5. 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.”

  6. 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.

  7. 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.

  8. 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.

     

  9. 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.

  10. 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.