Remediating Quality Management Systems (QMS) to Meet New MDR Standards in the EU
Remediating Quality Management Systems (QMS) to Meet New MDR Standards in the EU
Part of the art of conducting a good gap analysis and remediation involves working closely with the staff charged with monitoring and modifying the QMS system as well as getting buy-in for the process so that all parties feel that they are on the same side of the table working in harmony to achieve compliance excellence.
Recently, Wipro had the opportunity to partner with an organization going through this process. By tackling each step of the process thoughtfully and carefully, we were able to successfully remediate their QMS - and now we’re sharing our learnings with you via this white paper.
In this white paper, we cover important topics including:
+ The key objectives of the new MDR regulations
+ The most significant shifts moving from MDD to MDR
+ A case study involving one of our customers shifting to MDR standards
+ Updates and newly created processes based on these changes
+ And more