Search
  • Andrew Wu

The Essential Guide to Preparing Your QMS For EU MDR


You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020.

Link to the Article: https://www.greenlight.guru/blog/qms-eu-mdr

The European Medical Device Regulation (EU MDR) has been created to replace the former Medical Device Directive (MDD) over a 3-year transition period, which comes to an end on May 26, 2020. These new requirements involve several changes that medical device companies must be prepared for, including things like device classification and updating your QMS.

We will cover some of the most important action items that must be taken ASAP by companies.

  • Understand the key changes in the MDR

  • Documentation and requirements for each category of Economic Operators within the supply chain

  • Updates to comply with SPRs

  • Incorporating UDI and EUDAMED into your labeling and traceability SOPs

  • Procedures for the regulatory compliance strategy

  • New requirements for Implantable devices

Please contact us at info@rookqualitysystems.com if you have any questions.

Sponsored by

#EUMDR #QMS #UDI #EUDAMED #SPR #CompliantHandling #Vigilance

27 views0 comments

Recent Posts

See All

New FDA Guidance Regarding Bench Testing

The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports are typically not

Archive
Search By Tags