Regulatory Affairs Service

Do you need support in setting up a quality management system? Would you like to manufacture or market a medical device or in-vitro diagnostic product under your own name? You do not have the expertise to cover the position of QMB or PRRC in your company?

Do you need further support on regulatory and strategic issues for the success of your products?

Our team of experts will support you in setting up a quality management system and in obtaining EU authorisation for your medical devices and in-vitro diagnostics. Our aim is not only to provide you with conceptual and advisory support, but also to play an operational role in setting up your documents and processes.

Our service includes:​

• Provision of an external Person Responsible for Regulatory Compliance (PPRC)​
• Provision of an external QMB​
• Setting up a quality management system in accordance with ISO 13485:2021​
• Conducting internal audits within the scope of ISO 13485:2021​
• Review and preparation of technical documentation in accordance with MDR 745/2017 or IVDR 746/2017​
• Review and advice on specific topics such as ​
  • Risk Management​
  • Clinical Evaluation​
  • Usability​
  • Software Lifecycle​
  • Post Market Surveillance

We will create a customised service offer based on your content and time requirements, your wishes and ideas.