Insights archive | Sagentia Innovation

Insights archive

The Medtech Conference 2022 – Top 5 issues for new product innovation

Every year Sagentia Innovation participates in The Medtech Conference, Boston, and Rob Morgan, VP Medical, would like...

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...
Medical Regulation 04 February, 2022

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...
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