October 4, 2022
Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions has increased annually by approximately 10-15% over the past five years. In addition, costs for post-market surveillance have been growing, [...]
March 29, 2022
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up [...]
March 22, 2022
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification of new or [...]
March 22, 2022
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification of new or unknown software through an understanding and analysis of two critical [...]
March 15, 2022
The new clinical trial regulations that are in place right now will streamline applications and increase transparency. The current clinical trials regulatory framework for the European Union (EU) has entered into effect this [...]
March 8, 2022
Women remain underrepresented in science, technology, engineering, and mathematics (STEM). According to the latest report from the National Girls Collaborative Project, women make up only 34% of the STEM workforce with only 16% of engineers [...]
March 8, 2022
For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]
March 1, 2022
Making a medical device means you're in the business of saving lives—and that's nothing to sneeze at. As if that wasn't enough pressure, you now have to deal with the labyrinthine EU certification process. [...]
February 24, 2022
The European medical device regulations (MDR) provide a minimum standard in Europe for health equipment manufacturing or exporting. We know it is hard enough to remember the new changes and guidelines when it comes to MDRs. Keeping [...]
February 22, 2022
The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all [...]
February 15, 2022
Medical device manufacturers conduct clinical investigations to ensure that products meet the rules. To most, it is simply a necessity in order to get their medical devices approved. However, in some cases, the clinical [...]
February 10, 2022
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! [...]