We drive safety in medical devices by helping our clients meet industry requirements in a cost-efficient way.
We ensure our clients are compliant with the relevant applicable medical device standards like IEC 62304, IEC 82304-1, ISO 14971, ISO 13485 and IEC 60601. Our services include:
- Project gap analysis: identifying gaps with respect to safety requirements and determining the best way to overcome them, given specific project and client needs.
- Safety management & safety case preparation: managing functional safety across the medical device development lifecycle, including dealing with safety cases.
- Independent Safety Assessment (ISA): compiling and reviewing all project safety artefacts to assess compliance with the applicable regulation.