EU-MDR has a global impact on Quality Management Systems. An effective MDR-compliant QMS is a dynamic pool of risked-based decision making processes and proactive procedures for complying with evolving regulations and increased monitoring needs.
Did you know that although ISO 13485 is not yet harmonized with EU-MDR, it might serve as a guide of conformity to its requirements?
Does your current QMS meet the additional requirements? We have prepared a table that corresponds ISO clauses with EU-MDR requirements as a guide.
Contact Evnia for more resources and tailored solutions that will bridge your operational reality with current regulatory expectations!
