FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket...
The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental...
For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical...
In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...
For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made...
November 14, 2019, Ashland, MA – MEDIcept Inc., a leading international Quality and Regulatory consulting firm focused on medical device and invitro diagnostics, and ACMP Consulting, Acton, MA have entered into an agreement to provide Clinical Research Organization...
“Medicept is an outstanding quality consulting firm which never misses a beat on matching the client’s Quality needs with the daily, regulating and mandated FDA and ISO requirements.”
“MEDIcept has been easy for all to work with, they know a lot about out company and everyone actually enjoyed working with them. Their consultant, Fides Maldonado conducts herself as a professional, she added value to many projects and communicates ...
“MEDIcept was effective at helping refine my thinking regarding new methods for RCR and helped prepare the new invention for commercialization. Very efficient communication and offered relevant feedback throughout the process. MEDIcept is a valuable resource for any surgeon-inventor.”
“Thank you, I am confident your assistance will go a long ways with the PV team as we prepare for the inevitable FDA audit. I now consider your organization part of the PV team and believe your collaboration will be ...
