Aug 3, 2020 | Documents, News
On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as the FDA’s plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The FDA has stated that additional details will be laid out in...
Jul 29, 2020 | Clinical Evaluation, Documents, News
The FDA has published the final version of a guidance document it initially issued in March 2019 entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The document outlines how the agency plans to implement uniform procedures for...
Jul 17, 2020 | Documents, Services
A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De...
May 6, 2020 | Documents, News
Since their introduction two decades ago, hydrophilic and hydrophobic coatings on intravascular devices such as catheters, wires, and delivery systems have proven highly popular for decreasing the frictional force when the devices are introduced into the vasculature....
Dec 23, 2019 | Documents, News, Risk Management
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...
Nov 19, 2019 | Clinical Evaluation, News
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...
