Customised implants

Purpose and goal: ** Denna text är maskinöversatt **

The primary goal has been to produce the necessary regulatory documentation according to MDR for the specially adapted implants that have been developed. Within the project, the parts concerning risk management, clinical evaluation and biocompatibility for the implants have now been compiled so that the regulatory requirements are met according to MDR.

Expected results and effects: ** Denna text är maskinöversatt **

With the necessary regulatory documentation, the next step can be taken before an upcoming market introduction. Contacts are available with an international manufacturer whose products have proven to work very well in combination with the specially adapted implants. Through their contacts, a number of cases are planned to be implemented together with "key opinion leaders" in the larger European markets.

Approach and implementation: ** Denna text är maskinöversatt **

An external consultant has been hired to help with the preparation of the regulatory documentation where work has been carried out with recurring meetings, reviews and discussions. In addition to the documentation itself, the understanding and knowledge within the company for the regulatory work has also been increased.