Tag: medical device and diagnostics

Medical and Regulatory Affairs

Best Practices For Interventional Cardiovascular Medical Device Trials In APAC

The Asia-Pacific region (APAC) is prepared to be key in addressing one of the word’s great health concerns. In our aging society, heart disease has become one of the most significant health problems worldwide. Its incidence is forecast to increase steadily as the number of people aged 60 and older is expected to double by...

Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

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 mechanisms...

Consulting

FAQ: How the EU Medical Devices Regulation Affects Existing Products

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 answer...

Medical Device and Dermatology Experts Presenting at MAGI East Conference

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,...

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...

Consulting

Planning For Quality In Your Medical Device Clinical Trials

The concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharmaceutical and medical device worlds for more than a decade. Most large sponsor companies in the medical device industry have adopted RBM in their clinical trials. Meanwhile, smaller medical device companies, seem to be slower to embrace the concept. Despite years of conversation and availability of regulatory guidance from...

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

EU Medical Device Regulation: Your Questions Answered

With the European Union (EU)’s new Medical Device Regulation (MDR) taking effect in May 2020, device manufacturers transitioning to the EU MDR face a host of questions. Among them are: Is it possible to avoid compliance with the MDR? When should I be compliant? How will this affect my new product development? How does this affect my products currently on...

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,...