Overview
Developing a medical device requires orchestrating multiple external partners — testing laboratories, R&D contractors, notified bodies, and patent counsel. Mansour Consulting acts as your experienced regulatory interface, ensuring that external work is properly scoped, executed to applicable standards, and documented in a way that supports your regulatory submissions.
R&D Coordination
We assist manufacturers in structuring their product development activities to align with FDA design controls (21 CFR 820.30) and ISO 13485 requirements from day one — not as an afterthought.
- Design history file (DHF) planning and structure
- Design input/output traceability matrix development
- Risk management integration per ISO 14971
- Coordination with contract R&D organizations (CROs)
- Technical file and design dossier preparation
Laboratory Testing
We help you select the right testing laboratories, define appropriate test protocols, and ensure results are documented in a format acceptable to FDA and international regulators.
- Biocompatibility testing strategy (ISO 10993 series)
- OECD GLP / OMAL compliant study planning
- Electrical safety and EMC testing coordination (IEC 60601)
- Sterility, packaging, and shelf-life validation
- Bench and performance testing protocol review
We work with accredited third-party labs and can recommend facilities with proven FDA submission track records.
Patent Application Support
While we are not a law firm, we support your patent strategy by providing the technical and regulatory narrative that underpins strong intellectual property filings — and by coordinating the interface between your patent counsel and your regulatory team.
- Technical description drafting for patent applications
- Prior art landscape review (regulatory perspective)
- Coordination with patent attorneys on device claims
- FTO (freedom to operate) regulatory input