However not yet full published, the new MDR causes a hurricane in the medical device world!
Each company already needs to analyse and make sufficient action planning and resource available with regards to clinical evaluation, PMS, risk management, market traceability and transparency and regulatory compliance.
You can download the MDR (with table index !) here.
Annex numbers are different, Scopes enlarged, definitions fine-tuned and a lot of new requirements with enhanced Notified Body surveillance.
LVL Mediphar can help you in order to coach your internal people to accomplish these huge task.Downloads
Are you ready for implementing the new ISO 13485?
ISO 13485 vers. 2016 has been published and a 3 years transition period is running.
Even if you have a good working QMS running, some basic GAPS needs to be tackled.
I’ve summarized the main differences and how you should interpret and implement these Gaps.
You may free download it from here.Downloads