Latest news

Approaching FDA ahead of formal premarket submission can make the regulatory process smoother for medical devices. But deciding the best moment to make contact requires careful consideration. Medical device companies often want to find out the type...
Medical devices News
What’s the best way to go about obtaining FDA authorization to market a medical device? This is the million-dollar question frequently put to us at TSG. Naturally, every situation is different, but the single most important factor is a regulatory...
Medical devices News
FDA’s legal and regulatory framework The definition of a medical device FDA’s risk-based classification of a device Paths to market for medical devices 3 primary types of premarket submissions 510(k) premarket notifications De Novo requests...
Article Medical devices
Haven't found what you were looking for?

Servicesarrow pointing right

We help companies navigate the regulatory landscape across a range of geographies and jurisdictions. Read about the comprehensive range of services we offer.

Professionalsarrow pointing right

Our regulatory specialists and scientists address all aspects of product registration and ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.

Contact us