Regulatory & Compliance Perspectives

  1. 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.

     

  2. 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.

  3. 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.

  4. 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. 

  5. 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.

  6. 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.

  7. U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry 1/3/2025

    The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?

  8. 9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond 12/17/2024

    Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.

  9. The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025 12/10/2024

    Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

  10. Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions 12/9/2024

    In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.