Memphis Regulatory Consulting, LLC (MRC) offers regulatory consulting services. Both partners have advanced degrees in engineering. The technical perspective of MRC brings a deeper level of understanding to the regulatory strategy behind preparing documentation and gaining approval and clearance for medical devices. Services include expertise in the following regulatory areas:
- Project and submission strategy: regulatory plans
- 510(k)'s: special, traditional and letter to file documentation
- Technical files and design dossiers
- STED and shonin documentation
- International registrations
- IDE: pre-clinical summary, protocol drafting, and manufacturing sections
- PMA: pre-clinical summary, clinical data summary, and manufacturing sections
- Design control documentation: development and implementation of procedures, completion of design history files
- Labeling and Instructions for Use (IFU)
- Change controls: design, manufacturing, labeling and regulatory filings
- Due diligence
- Scientific literature reviews
- Medical Device Reporting: review and documentation
- Training
- FDA and notified body audit preparation and participation
Please, contact us and let us know what we can do for your business.
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