Push-Med’s team is highly experienced in developing regulatory strategies, marketing applications and regulatory submissions for US, EU, Australia, Canada and other countries.

REGULATORY STRATEGIES:
We advise clients on questions regarding classification, regulatory processes, special requirements, etc. and assist in the development of strategies for successful submissions.

We advise and prepare clients for pre-submission meetings with Regulatory Agencies (FDA, Notified Bodies, etc.).

REGULATORY SUBMISSIONS:

We prepare entire regulatory submission (e.g., IDE, PMA, 510(k), “de-novo” request, DMF, Technical File, Design Dossier, “Medical Device Licence”, etc.) or individual sections of a submission.

We review client submissions for potential FDA issues and completeness.

Additional information on services we provide can be found in the following links:

FDA MARKET AUTHORIZATION

POST-MARKET COMPLIANCE (USA)

CE-MARKING

POST-MARKET COMPLIANCE (EU)