Bringing order to complexity — so your device reaches the market safely and on time
Regulatory compliance isn't a final hurdle — it runs through every stage of medical device development. We help manufacturers build quality in from the start, navigate global regulatory requirements with confidence, and arrive at certification with everything in order.
From design control and documentation to post-market surveillance, our QA and regulatory affairs services are built around the standards that matter most to regulators, notified bodies, and patients.
Design Control & Documentation
Robust design control is the foundation of a compliant device. We help clients implement processes that maintain full traceability across design inputs and outputs, verification and validation activities, and change control procedures — documented in line with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and MDR, and structured for smooth audits and regulatory submissions.
Regulatory Affairs & Compliance
Bringing a device to market means navigating a complex, overlapping landscape of international requirements. We support clients in achieving compliance with ISO 13485, IEC 60601, IEC 62304, and 21 CFR Subchapter H, with hands-on experience preparing technical files, supporting audits, and meeting post-market surveillance obligations. We also bring expertise in GDPR and TÜV certification — covering data protection and quality assurance in the same regulated environment.
Certification Support
We provide end-to-end support for certification — producing the full set of software artefacts and documentation that regulators and notified bodies expect. This includes requirements specifications, design documentation, code reviews, test plans and reports, configuration management files, and final certification packages, all structured for traceability and audit readiness.
Training & Knowledge Transfer
Regulatory knowledge shouldn't sit with one person. Our training programmes are tailored to each audience — from engineers to quality managers — offering practical guidance on regulatory frameworks, implementation strategies, and the day-to-day impact of standards. The goal is to help teams work compliantly with confidence, not just at launch, but throughout the product lifecycle.