Dec 1, 2020 | Documents, News
As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...
Aug 9, 2020 | Risk Management, Documents
Introduction One of the most challenging elements of risk analysis is the assignment of Harms and Severities to a particular hazardous situation. On the surface, describing the consequences of the sequence of actions that lead to exposure to a hazard seems pretty...
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 Research, 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, News
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....