Regulatory

Regulatory management for us means to ensure product safety and fulfilment of regulatory requirements in order to launch your product.

We have the regulatory and engineering experience and competence to help you to efficiently achieve a CE mark, or if you plan to launch your product on the US market, a 510(k) filing or a premarket approval.

Our core processes consist of

  • Design Controls
  • Document Controls

We are ISO13485:2012 certified at our offices in Stockholm and Lübeck and our processes are in accordance with QSR requirements.

We typically have several medical device development projects going on in parallel. Our design controls and document templates assure that project planning, hazard analysis, risk mitigations and all other required activities are performed and documented during the project. Towards the end of the project we put together the required documentation to allow the products to be sold.

Whether it is a 510(k) application, or a product requiring CE marking, we help our customers navigate through the regulatory acceptance process.