We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean and expound the most important points for you to know as a medical device company.
Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.
Paper-based quality management systems are no longer an option. The right quality management software platform can save time, money, and allow you to focus on quality.
Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.
The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.
How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.
Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.
If you find yourself in this situation, learn how to respond to FDA 483's & warning lettering (includes a free response template)
A step by step guide to complying with ISO 13485 and FDA quality management system requirements for medical device companies.
Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.
Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.
Learn what is expected from regulators & how you can start to use risk management as a tool - not a checkbox activity.
Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.