Medical Device Development and Regulatory Approval

Intended Use & Indications for Use

We can help you clearly define what the device does, for whom, and in what setting. This is needed for any type of regulatory filling.

Device Classification

Determine risk class (U.S.: Class I, II, III; EU: Class I, IIa, IIb, III) → drives regulatory pathway.

Regulatory Pathway Analysis

We can help you choose the appropriate route regulatory pathway: 510(k), De Novo, PMA (U.S.), MDR CE mark (EU).

Predicate Device (U.S.) / Similar Devices (EU)

For 510(k) we can help you identify and find legally marketed similar device; for EU MDR we can help demonstrate equivalence if applicable.

Clinical Evidence Requirements

We can help you analyze the for need clinical trials or can determine if your project ad leverage literature, bench testing, prior data as part of its regulatory filling.

Regulatory Submissions Plan

Outline timeline and deliverables for pre-submissions, submissions, audits, etc. We can optimize you filling, your interactions wait the FDA and assure quick and compliant submissions.

Labeling & Claims Strategy

Our consultant can help you ensure your marketing claims align with approved indications and evidence. Our Medical-Legal review will assure compliance of your marketing material and sales strategies.