Regulatory consulting

  • Adaptation to the European Regulations IVDR and MDR.
  • Elaboration of technical documentation of medical devices, for CE marking and other markets.
  • Risk analysis.

Clinical evaluation and performance evaluation

We have medical experts who can help you with the clinical research strategy and the writing of the Clinical Evaluation and Performance Evaluation Reports so that the process is as fast and as simple as possible.

Quality Management Systems

We implement your management system based on ISO 13.485 that best suits your Organization.

Legal Registration

We help you with the registration of your facilities and your products both in Europe and in other countries.

Internal audit

We have qualified auditors, whether you need to audit your company or your subcontractors.

Training

Our courses will be adapted to your company. We design your training in a personalized way so that your staff can take full advantage of it. We also do open courses. Ask us about our training catalog!.

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