Ensuring products meet global safety, performance, and cybersecurity standards is essential for market approval and patient safety. Our compliance engineering supports device manufacturers in achieving regulatory approval while maintaining innovation, efficiency, and reliability.
We've taken products through IEC 62304, ISO 13485 and CE/UKCA often enough to know which decisions made in week one determine whether week fifty goes smoothly.
Bringing a device to market requires a clear regulatory pathway. We provide strategic guidance and technical documentation to help companies navigate FDA, MDR, UKCA and other regulatory requirements.
Device compliance demands rigorous risk assessment to ensure safety and regulatory approval. In medical, we integrate ISO 14971-compliant risk management into every stage of development.
Regulated devices must adhere to strict lifecycle requirements. We ensure compliance with IEC 62304 for both embedded and standalone medical software, helping manufacturers meet safety and performance standards.
Medical electronics must comply with IEC 60601-1 and IEC 60601-1-2 to ensure electrical safety, electromagnetic compatibility, and reliability in clinical environments.
Compliance shouldn't be an afterthought. We integrate regulatory considerations into design to reduce delays, minimise compliance risks, and ensure a smoother approval process.
Regulations evolve, and post-market compliance is just as critical as pre-market approval. We help device companies monitor performance, manage risks, and stay up to date with regulatory changes.
Approvals achieved, audits passed. Recent examples.
Tell us where you are in the process. We can join at any stage, from conception to launch.
