SERVICES
Regulatory:
- Regulatory strategy (regulatory research, initial FDA contacts, pre-submissions, device classification, writing, submitting and supporting your regulatory submission)
- Regulatory submissions: US FDA, EU, Canada
- Product labeling and packaging development and/or review
- Coordinate product testing (biocompatibility, electrical safety/EMC, biocompatibility, sterilization validation)
- Regulatory intelligence and guidance interpretation
Quality Systems/Compliance:
- Quality System design and implementation
- Internal audits
- Assist with third-party inspections/audits (US FDA, ISO)
- Post-market Compliance communications: Responses to 483s and Warning Letters, Field Actions (recalls, market withdrawals, field corrections), MDR/Adverse Event reporting
- Training: develop training materials, coordinate/deliver employee training sessions
Design Control:
- Develop/review/audit Design History Files, Technical Files, Design Dossiers
- Testing coordination: Electrical safety, materials characterization, biocompatibility, shipping/packaging
Clinical Studies:
- Clinical trial strategy, protocol development and/or review
- IRB submissions
- Clinical trial monitoring
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