Miscellaneous

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations. [...]

    For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a new development in the clinical trials regulation means what you [...]

Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a lot, usually till your eyes bleed, but as soon as you get [...]

The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find the answer. But, in reality, research is a messy process that often involves [...]

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant enough, can result in years of delay in getting a CE mark. [...]

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity [...]

All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools are especially essential since medical practitioners use them to identify, treat, and manage [...]

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and well-executed QMS is your security man who controls what goes in and [...]

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no [...]

This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff in the various parts of Post Market Surveillance (PMS) for MDR compliance! [...]

The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means [...]