Remediation & Regulatory Compliance
Quality systems, audit readiness, technical documentation, as per regional regulatory norms.
Overview
Regulatory, quality and remediation support for medical device organisations — from technical documentation and risk management through to post-market surveillance.
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Capabilities
Our Engineering Capabilities
Regulatory
- Regulatory Submission
- MDR / IVDR Compliance
- Technical Documentation
- UDI and Labelling
Quality
- QMS
- TMV
- Complaints Handling
Clinical & Post-Market
- Clinical Evaluation (CER)
- Post-Market Surveillance
Safety & Testing
- Risk Management
- Product Functional Testing
- Toxicology