Healthcare & Devices
ISO 13485 design controls and post-market surveillance support.
Quality assurance for healthcare & devices projects
Medical device quality is regulated end to end: design controls before launch, and post-market surveillance for the life of the product. Our work supports ISO 13485 organisations through design history file discipline, risk management to ISO 14971, and the MDR/FDA evidence obligations that follow the device into the field.
Where healthcare & devices quality typically fails
Design inputs without verification evidence, or changes without impact assessment, are the most common notified-body findings. We audit the DHF for traceability from input through verification and validation to transfer.
ISO 14971 files are often written once and never revisited. We connect risk management to post-market data so field experience actually updates the risk file.
MDR raises the bar on PMS plans, PSURs and trend reporting. We assess the surveillance system and complaint handling process against the regulatory obligation, not against the previous directive.
What we deliver on healthcare & devices assignments
- ISO 13485 internal audits and certification readiness assessments
- Design history file and design control traceability reviews
- ISO 14971 risk management file assessment
- Complaint handling, vigilance and post-market surveillance system review
- Supplier controls and contract manufacturer audits
Other industries we serve
Oil & Gas
Upstream, midstream and downstream QA, welding and NDE oversight.
Power & Energy
Generation, transmission and renewables quality and commissioning.
Mining & Minerals
Site QA, materials verification and turnover assurance.
Water & Wastewater
Regulated utility assurance and asset-integrity programmes.
Planning healthcare & devices work in North America?
Send us your scope and applicable standards — we'll respond within one business day.