Quality & Regulatory Support
Your Regulatory Partner in Precision and Performance
Bringing a medical device to market requires more than just great engineering. It demands meticulous documentation, robust testing, and expert guidance through regulatory frameworks. At Medisurge, we partner with OEMs to ensure quality and compliance are embedded throughout the development process — reducing risk, accelerating approvals, and building confidence.
What We Offer
Full-Spectrum Regulatory Support
- Risk management documentation (e.g., DHF, DMR, DHR)
- Design verification and validation (V&V) planning
- Functional and performance testing
- Process validation (IQ, OQ, PQ)
- Device history record creation and tracking
Compliance Consulting
- FDA and ISO 13485 alignment
- Audit preparation and support
- Remediation services for non-conformance
- UDI and labeling strategy guidance
Quality Systems Integration
- Embedded quality control checkpoints
- Final inspection and batch release protocols
- CAPA and non-conformance tracking
Our Approach
Partnership Over Paperwork
Our regulatory and quality team doesn’t just check boxes. We collaborate directly with your engineering and operations staff to understand your device, mitigate risks, and ensure your documentation and validation meet the highest global standards.
Built for Customization
Whether you need light-touch support on a single submission or a fully integrated QMS and documentation buildout, we tailor our services to fit your project stage and internal team structure.
Why It Matters
- Accelerate time to market with clean documentation
- Reduce risk of delays due to incomplete or non-compliant records
- Impress regulators and notified bodies with professional preparation
- Improve product consistency and patient safety through process discipline
Ready to Build With Confidence?
Medisurge has the systems, people, and experience to keep your medical device development compliant, responsive, and inspection-ready.
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