Regulatory & Compliance Perspectives

  1. Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm 6/6/2024

    The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.

  2. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

    There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.

  3. 5 Innovative Ways To Bring DHTs To Market Successfully 5/30/2024

    Real-world examples demonstrate how digital health technology (DHT) developers can navigate the regulatory pathway while optimizing opportunities for downstream patient access.

  4. Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155 5/22/2024

    The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?

  5. What You Should Know About The FDA's New Final Rule On LDTs 5/14/2024

    The FDA made a small change with big consequences when it amended its definition of in vitro diagnostics. Here’s what it means for lab-developed tests.

  6. 3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption 5/13/2024

    For in vitro diagnostic manufacturers entering the EU market, the key lessons to leverage from EU MDR implementation include early QMS preparation and two other key lessons.

  7. 4 Critical Focus Areas For Medtech Compliance Leaders 5/9/2024

    These four approaches are important for you as compliance leaders at medical device/medtech companies to create impact within your organization.

  8. A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices 5/8/2024

    Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

  9. AI-Enabled Medical Devices In India: Opportunities And Challenges 5/7/2024

    India holds a lot of promise for the medical device sector. But can its regulations catch up with the with growing concerns about AI, security, and bias risks?

  10. China In The Global Medtech Industry: Equal Parts Promising And Uncertain 5/1/2024

    While China is the world’s second biggest market, its activities are mostly focused on its own internal market and a few others. Some new developments are promising, and others raise questions.