The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people [...]
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin with [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, [...]
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 [...]
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the medical [...]
Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you [...]
Software as a Medical Device
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, [...]
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final [...]
