Successful Strategies for Medical Device FDA & CE Approval

sterlingmedical...
How much trouble and effort will it take to get FDA and CE Approval for my medical device?
Regulators want to see a very specific design process, strong quality control, robust risk management and an airtight submission package. At Sterling Medical Devices, the FDA has accepted our thorough Design History Files (DHF) every time, showing that we have tried to think of every possible scenario through software verification and medical device testing. We ensure that the medical device software and medical device hardware are doing what they are supposed to be doing and designed to do.
Learn more from Bruce Swope, VP of Engineering, who has over 25 years' management experience in medical device development, and John Campbell, Director of Quality, who has over 20 years in medical device development, device testing and verification.
Contact Bruce to learn more.
Visit: sterlingmedical...
Email: [e-mail]
Call 201-227-7569 x2.