How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.
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.
"I was actually a little nervous going into the audit, because it seemed too effortless."
“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger company; they send over a form asking about quality system, DC, RM, and if it’s not in place it’s going to cost you a lot of money.”
"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."
"I was actually a little nervous going into the audit, because it seemed too effortless."
By Jon Speer
Quality Digest June 20th, 2018
By Jon Speer
Quality Digest April 30th, 2018
By Jon Speer
MedCity News April, 23rd 2018
