Regulatory Assessments and Strategies for launching medical products into Multiple Markets
Regulatory Classification, and identification of consequent submission requirements
- US Medical Device Classifications per 21CFR - US Product Code Assessments - US FDA: 513(g) Requests - Requests for Designation (RFDs) - 510(k) Predicate Analysis/ De Novo petitions - European MDD Classifications per Annex IX rules - Determination of applicability of Directives - Identification of applicable Guidance Documents and Standards, including FDA-Recognized Consensus Standards
Pre-submissions and Pre-IDE Meetings
Preparation of materials and guidance for communications
Design Control Procedure Implementation Meet 21 CFR 820.30 and ISO 13485 requirements to assure efficient and compliant product development activities and regulatory submissions
Technical File (Design Dossier)/ Design History File Creation
Product Development Plans (with defensible timeline assignments)
Risk Management SOPs and Reports, including Risk Assessments (FMECAs, Hazard Analyses) and Benefit/ Risk Assessments
Design Verification and Validation plans, protocols, and reports
- Safety and Performance - Sterilization, Shelf Life (Storage and Transportation) - Biocompatibility Evaluation, including Toxicological Risk Assessments
Labeling preparation and review, including Instructions for Use
