Regulatory strategy for Navari Surgical AB.

Purpose and goal:

The objective of the project was to further develop work related to QA/RA questions, where we as a company would strengthen our expertise in the areas of regulatory navigation and regulatory strategy with support from an external consultant. The objective of the project is well met and the work carried out with the help of an external consultant has taken the company one step further, from a regulatory perspective.

Expected results and effects:

As a result of the work carried out, a regulatory strategy has been developed for Navari and its first product. Classification according to MDR has been identified and applicable standards have been listed. A plan for the establishment of a QMS has been designed and a documentation system with relevant templates has been developed. A regulatory analysis comparing the regulatory paths for CE mark vs FDA approval has also been conducted and material for a strategic decision has been developed.

Approach and implementation:

The project was carried out in two stages. The first step included a training for all employees in MDR and ISO13485. This training was carried out on site in Oslo with our consulting partner for two days in December 2022.

The second step has included regular digital workshop sessions, one hour per week, where the QARA manager at Navari, together with an externally hired consultant, worked with regulatory issues linked directly to the company and its product. This ongoing work has resulted in the development of a regulatory strategy and a plan for a QMS.