Regulatory & Compliance Perspectives

  1. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

    The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

  2. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

    One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

  3. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

  4. Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters 8/19/2025

    This article focuses on practical strategies for medical device companies to strengthen their quality management systems and develop proactive programs that anticipate issues before they attract FDA action. 

  5. Regulatory Planning In Early Medtech Development Is The Recipe For Success 8/18/2025

    Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to obtain clearance or approval. That mindset is no longer enough. 

  6. The U.K. Now Classifies Ambient Voice Technology As SaMD 8/14/2025

    The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD). 

  7. The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us 8/12/2025

    FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.

  8. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  9. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

  10. Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance 7/7/2025

    The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.