Regulatory & Compliance Perspectives

  1. What Does the Federal Risk Management Framework Mean for Medical Device Developers?

    Federal buyers make up an enormous and attractive market for medical device manufacturers. But tapping into this market can have unexpected pitfalls for medical device developers.

  2. Ready or Not: 4 Lessons to Prepare For the EU MDR

    After a decade of effort, European legislators have published the new Medical Device Regulation (MDR), which brings sweeping changes to how medical devices gain and maintain approval across the European Union.

  3. FDA’s Class II Special Controls Designations Are On The Rise; How Will Your Device Be Affected?

    Over one-third of all Class II devices now have “Special Controls” designations from FDA. The rate of such classifications in the last seven years has increased by over 240 percent (Desjardins 2010). What is driving this trend?

  4. From Startup To Major OEM: How Medtechs Can Embrace Connected Technologies

    As patient-centered care and mHealth have become driving forces in health care, digitally connected health technologies have emerged as a solution to engage patients and collect data. But patient and provider adoption of these devices can be a challenge.

  5. MDSAP And Its Implications For Device Makers

    Manufacturers selling their products in multiple countries must comply with regulations in each country, which can be a complex and time-consuming process. Regulatory variations from country to country means different audits and processes are required. This article will help you navigate through those issues.

  6. When Regulatory Goes Wrong

    In spite of my preference for “happily ever-after” as detailed in a previous article, sometimes things do not go well for medical device companies as it pertains to regulatory affairs.

  7. Human Factors Align At The RAPS 2017 Regulatory Convergence

    Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here. 

  8. Learn From Past Mistakes: Preparing For MDSAP And International Commercialization

    In today’s complex and constantly changing medical device world, it is more important than ever to fully understand regulations — particularly those regarding communication with Notified Bodies — to be able to comply with quality and regulatory requirements in Europe.

  9. 3 Medtech Regulatory Successes (That Started As Failures)

    These tales prove that it's possible to snatch victory from the hands of regulatory defeat when responding to adversity with open-minded persistence.

  10. How to Prepare Your Design History File For An FDA Inspection

    For some medical device companies, an FDA visit can be scary and stress-inducing — if you don’t have your ducks in a row.