Insights archive
When should you contact FDA about a new medical device?
Medical device companies often ask us about the best time to contact FDA for regulatory guidance. There’s a delicate...
FDA IVD review process has changed; how should manufacturers adapt?
A surge in premarket submissions during Covid-19 led the FDA to realign its review process for IVDs. Consequently, many...
Holding medical devices hostage
As medical devices become increasingly connected, security is emerging as a major issue, prompting device companies and...
How 3D printing could be shaping our bodies and our futures
The recent guidelines released by the FDA are confirmation of a growing industry which incorporates 3D printing into...
