Even though it hasn't been fully published yet, 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 regard to clinical evaluation, PMS, risk management, market traceability and transparency and regulatory compliance.
You can download the MDR (including index table!) here.
Annex numbers are different, Scopes have been enlarged and definitions have been fine-tuned, next to plenty of new requirements with enhanced Notified Body surveillance.
LVL Mediphar can help you in order to coach your internal people to accomplish these huge tasks!Downloads
Are you ready to implement the new ISO 13485?
ISO 13485 vers. 2016 has been published and a 3-year transition period is currently in place.
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 can download your complimentary copy here for free.Downloads