Medical Technology
Medical Device Quality and Risk, MDR, FDA, and ISO 13485 Compliant by Construction
Medical-device development carries an evidence burden that no other industry asks for. TMG implements PeakAvenue's eQMS, document control, and ISO 14971 risk management for medical-technology and IVD manufacturers, configured for GAMP 5 validation, MDR / IVDR submission, FDA 21 CFR Part 820 design control, and the post-market surveillance loop that closes the regulatory cycle.
Aligned with every regulator your product file reaches
The platform we deliver is configured against the working set of standards that govern medical-device quality, risk, and validation.
The challenges we address
GxP validation effort drives implementation cost
Validating quality-related software in a GxP environment under GAMP 5 is rigorous by design. Documentation, traceability, and compliance evidence absorb engineering and quality time that would otherwise reach the product itself.
MDR, IVDR, and FDA timelines compete with development
Regulatory submission cycles are longer than they used to be and less forgiving of documentation gaps. Without end-to-end traceability between requirements, risk, verification, and post-market data, audits surface findings that delay market entry.
Risk management runs in parallel rather than integrated
When ISO 14971 risk activities are not connected to design inputs, verifications, and CAPA, the resulting documentation set is fragile. Reviews take longer, gaps appear in audits, and the linkage that the standards require is hard to evidence.
Post-market surveillance and CAPA disconnected from development
EU MDR and FDA 21 CFR Part 820 require structured post-market surveillance feeding back into the product file. Without that loop, field signals do not reach the design team in time to inform the next revision.
An eQMS that the auditor and the engineer can both work in
TMG configures, validates, and operationalises the PeakAvenue platform for medical-technology workflows, with the GAMP 5 validation deliverables built into the engagement, not bolted on after.
GAMP 5-compliant eQMS implementation
TMG delivers PeakAvenue's eQMS with the validation documentation set required for GxP environments. The system is configured for medical-device and pharmaceutical workflows and meets MDR, ISO 13485, and FDA 21 CFR Part 11 requirements out of the box.
Document control for SOPs, technical files, and design history
A central, version-controlled document management system holds all quality- and compliance-related documents under one structure. Integration with existing ISO 13485 and GxP systems is preserved; the audit trail is continuous and electronically signable.
Risk management linked directly to design and verification
Risks attach to design inputs, verifications, and mitigations across the product lifecycle. FMEA, hazard analysis, and fault tree analysis run on a shared platform that satisfies ISO 14971 and ISO 13485 design-control linkage requirements without parallel record-keeping.
Post-market surveillance with end-to-end CAPA logic
Customer complaints, incidents, and service feedback enter the same system that the development team works in. CAPA actions are tracked against the source signal and against the affected product family; the compliance record is a query, not a forensic exercise.
What medical-device sites have realised
The figures below are the platform-vendor-reported gains achieved by medical-technology sites that implemented the programme to depth. The realisation in any given engagement depends on the operating discipline that sustains the implementation, which is the work TMG is engaged for.
Engage TMG for your medical technology programme
The Mantua Group implements PeakAvenue's eQMS, document control, ISO 14971 risk management, and post-market surveillance for medical-device and IVD manufacturers operating under MDR, IVDR, and FDA 21 CFR Part 820. We bring the analytical rigour, the regulatory familiarity, and the implementation discipline that turns a software platform into a working quality system.