In the regulatory field we support companies to receive market clearance in Europe and USA including specialty competence in several areas such as risk management, software and clinical evaluations. We participate in national device registrations, 510k, PMA, recalls and warning letters, training sessions, European Authorized Representation, etc.
In the quality field we work with building and evolving quality systems, compliant with ISO 13485 and QSR. We help companies to be both efficient and compliant at the same time. This includes often implementation of Digital Signatures.
In the business development area we help MedTech companies to improve their processes, preferably with Lean methodology.