October 10, 2013

Time for a Regulatory and QMS Tidy Up

2013 is quickly drawing to a close – ensure you carry out a regulatory and quality management system (QMS) tidy up within your organisation before the Christmas break is here.

KD&A recommend the following tasks:

  • Complete product registration for medical devices (including IVDDs) that your organisation wish to place on the market in 2014.
  • Ensure all outstanding QMS activities are seen to. Review registers and forms to ensure they’re suitably complete.
  • Consider scheduling internal auditing, standards review, post market surveillance and management review activities for 2014 – adding reminders to your diary where useful.
  • Begin to prepare Technical Documentation for upcoming applications. Getting a head start on this will reduce the workload for early 2014.
  • Consider developing a regulatory strategy for upcoming medical devices – understand and prepare for the applicable regulatory requirements.

KD&A can assist your organisation with any regulatory tasks. Please do not hesitate to contact us for a personalised quotation.