Services
Regulatory Strategy & Submissions FDA Class I & II
Regulatory Strategy
- Research similar devices on market
- Medical Device Classification
- Regulatory Pathway Determination
Regulatory Submissions (FDA – Class I & Class II Medical Devices)
- Q-Submissions (Pre-submissions, SIRs, and other regulatory interaction)
- 510(k) Premarket Submissions (Traditional, Special, Abbreviated)
- De Novo Classification Requests
- 513(g) Requests
- Breakthrough Designation Requests
- STeP Program / Sprint
- Post-submission Support (RTA, AI, NSE, Refuse to Accept)
- Regulatory guidance for General Wellness Devices and borderline products
Non-Clinical Testing Strategy
- Benchtop testing plan and standards compliance
- Biocompatibility testing development and standards compliance
- Integration of design controls and special controls (when applicable) with testing plans
- Coordination with testing labs
Quality Management Systems (QMS) & Compliance
- QMS development per ISO 13485 and 21 CFR 820 (FDA)
- Gap analysis
- Risk Management per ISO 14971
Human Factors
- Development of human factors testing protocols for formative & summative usability testing
- Human Factors Documentation
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