- Analysis of the product to evaluate the feasibility of the project, its strengths and weaknesses;
- Product classification;
- Analysis of the ISO 13485 quality management system;
- Design of the necessary tests necessary to demonstrate the safety and the performance of a product.
- Implementation of risk analysis, clinical evaluation and clinical evaluation report.
- Development of post marketing surveillance procedures and plans.
- Follow up with the notified bodies (where foreseen) until obtaining the CE marking approval.
The CE marking process will change with the entry into force of the new medical device regulation (MDR 2017/745). The transition periods that will end in May 2020 is the right time to verify what impact the new MDR will have and what corrective measures will be implemented.