Luminance Health’s Medtech & Pharma experts have extensive knowledge in development, commercialization and lifecycle management of medical devices, in vitro diagnostics (IVDs) and combination products.

We have long-term experience in advising our clients to meet and implement the global regulatory requirements for medical devices (including software), IVDs (including companion diagnostics, genetic tests, and near-patient testing devices), and combination products.

We perform gap analyses and create, review and update technical documentation, clinical performance evaluations as well as quality and risk management systems according to respective regulatory frameworks.