MedTech regulatory and compliance support
Hands-on support across MDR, IVDR, clinical evaluation, technical documentation and quality systems required for compliance and market access.
Technical documentation preparation and review
Clinical evaluation and post-market documentation
Quality systems and audit readiness
Regulatory compliance across MDR, IVDR and FDA frameworks
Examples of support activities: prepare, review, remediation
Examples of support activities
Technical Documentation
→ Module 1 preparation
→ eCTD publishing
→ eAF preparation
→ Variations (IA, IB, II)
→ Renewals
→ Lifecycle maintenance
→ Agency interactions
Clinical, Scientific Documentation and Medical Writing
→ Clinical overviews and summaries
→ Medical writing
→ Bridging reports
→ Scientific justifications
→ Literature review
→ CRO coordination
Post-Market Documentation
→ CMC documentation
→ Technical development
→ Analytical support
→ Manufacturing documentation
→ Submission data packages
Risk Management
→ ISO 14971 Risk Files
→ Benefit-risk assessments
→ Usability files
→ Risk management (ISO 14971)
→ Human factors documentation
Quality Systems
→ ISO 13485 implementation
→ SOP development
→ Internal audits
→ Supplier qualification
→ Audit preparation
Regulatory Submissions
→ CE Marking documentation
→ MDR / IVDR submissions
→ FDA support documentation
→ Regulatory gap assessments
Document review and remediation
→ Technical File reviews
→ CER gap assessments
→ PMS remediation
→ Regulatory gap assessments
→ Risk File updates
→ QMS reviews
→ Audit findings remediation
Confidential discussion. No commitment. Practical guidance from day one.
Delivered by senior MedTech and regulatory experts
All services are delivered by experienced professionals with expertise in MDR, IVDR, FDA and global regulatory frameworks — ensuring compliant, audit-ready and market-ready solutions.
Need support with a specific document, activity or compliance project?
The examples shown represent only a selection of the activities we support. If your requirement is not listed, contact us to discuss your specific needs.
Confidential discussion. No commitment. Practical guidance from day one
