Category Archives: Medical Device and Diagnostics

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanismsRead more

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answerRead more

DURHAM, N.C., May 3, 2019 — Two of our top experts, Joanne Emmett, Vice President of Clinical Development Services for Medical Device and Diagnostics, and Jasmina Jankicevic, MD, MSc, CCRP, Dermatologist, Executive Director, Medical Affairs, will participate in three sessions at the MAGI 2019 East Clinical Research Conference in Boston. Emmett, head of medical devices,Read more

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines AgencyRead more

DURHAM, N.C., February 26, 2019 — The European Union’s new Medical Device Regulation will mean a lot of changes for device makers when it takes effect in May 2020. Now’s the time to prepare, and Premier Research will discuss how at a live webinar on Tuesday, March 12. Topics will include: When device makers needRead more

It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technologicalRead more

We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,Read more

The European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are putting a lot of pressure on the medical device industry. These are big changes with far-reaching implications, and if there’s a common denominator among them, it can be summed up in one word: more. In this episode of Premier Voices,Read more

DURHAM, N.C., September 05, 2018 — As global, multi-center medical device studies become more common, trial monitoring becomes more complex. At a live webcast on Wednesday, September 12 (11 a.m. EDT / 4 p.m. BST / 5 p.m. CEST), Premier Research will examine what it takes to ensure compliance with federal regulations, sponsor agreements, investigational plans,Read more

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years forRead more

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