Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and…
20 Nov 2025
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools…
20 Nov 2025
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes…
20 Nov 2025
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant…
20 Nov 2025
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find…
20 Nov 2025
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a…
20 Nov 2025
Vigilance Reporting Under the MDR: Insider’s Guide
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…
20 Nov 2025
Top 10 Literature Search Tools Every Medical Writer Should Know
Medical writers doing a literature search for a clinical evaluation report typically need three kinds of tools working together: a bibliographic database…
20 Nov 2025