Tag: medical device

Medical and Regulatory Affairs

The Role Of Notified Bodies Under The EU Medical Devices Regulation

The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical...

Medical and Regulatory Affairs

Premier Research Names New Medical Device Research And Regulatory Process Experts

DURHAM, N.C., March 8, 2019 — Premier Research has added key expertise to its global CRO operations by naming three new medical device and diagnostics specialists. Joining Premier Research are Vicki Gashwiler as executive director of clinical development services, medical device and diagnostics; and Sundeep Shrivastava as executive director of clinical development services, medical device...

Data Management & Biostatistics

3 Key Takeaways on Choosing the Right Committee for Medical Device Trials

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 Agency...

Medical and Regulatory Affairs

The Evolution of Regulations for Digital Health Products

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 technological...

Clinical Research: Phase 1 - Phase 4

DMC? CEC? Your Guide to Translating Clinical Trial Shorthand

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,...

Medical and Regulatory Affairs

Premier Voices #6: Operationalizing the New MDR With Janet Kube (Part 2)

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,...

Consulting

The Role Of Clinical Endpoint Committees In Medical Device Trials

This webinar discusses the value of clinical endpoint committees in medical device evaluation programs and explore the process of organizing, managing, and implementing a centralized adjudication process for standardizing study endpoints. CEC-adjudicated endpoints may be used in critical decision-making processes including power estimations, periodic safety reviews by data monitoring committees or data safety and monitoring...

Medical and Regulatory Affairs

Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

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 for...

Medical and Regulatory Affairs

Demystifying the Differences Between DMCs and CECs

In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, the investigational plan and the requirements set forth in the Investigational Review Board (IRB)...

Study Design

Considerations for the Design and Execution of Medical Device Trials

While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed. Here are a few of the key differences: Requirement for a clinical trial When studying...