Services
End-to-end medical device development and regulatory support, from first concept through FDA submission and U.S. launch.
Regulatory Strategy & FDA Pathway
Determine the right FDA pathway, device classification, product codes and regulatory requirements.
Quality Management Systems
Establish an ISO 13485 and FDA QMSR compliant quality system, scaled to your stage.
Medical Device Design & Development
Multidisciplinary engineering from concept to design freeze.
Verification & Validation
Test plans, protocols and reports that prove your device meets its specifications and standards.
Manufacturing & Process Development
Get from prototype to repeatable, validated production.
FDA Submissions
Prepare and manage 510(k), De Novo and other FDA submissions through to a decision.
FDA Pre-Submissions
Get FDA feedback on your plan before you invest in testing and submission.
Where 510(k)s get stuck
Industry analyses estimate about two in three 510(k)s get an FDA request for more information in the first review. These are the usual causes, and how we prevent them.
- Weak predicate comparison
- We search predicates and settle the substantial equivalence argument before you design your tests.
- Missing biocompatibility evidence
- We build an ISO 10993 plan matched to how, and how long, your device touches the patient.
- Bench testing that doesn't answer FDA's question
- We write V&V protocols with clear acceptance criteria and a sample size you can defend.
- Thin software documentation
- We produce IEC 62304 documentation alongside the code, not after it.
- Cybersecurity gaps
- We deliver a threat model, SBOM and security testing that meet section 524B.
- Labeling that overreaches
- We review labeling against 21 CFR 801 and your exact indications for use.