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FDA Guidance on Q-Submission Program FDA

FDA Guidance on Q-Submission Program

The Food and Drug Administration (FDA) has published guidance dedicated to the medical device submissions under the Q-Submission program. The document describes the regulatory requirements introduced under the appropriate framework and also provides medical device...

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MDCG Guidance on EUDAMED Alternatives MDCG

MDCG Guidance on EUDAMED Alternatives

The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...

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