Equip Course No EQ001 - Notified Body interactions training Online

£360.00 incl. tax*

This half-day online course will equip attendees with knowledge, skills and etiquette to enable a productive, beneficial and efficient working relationship between the manufacturer and their chosen conformity assessment body.

  • Background to conformity assessment bodies
  • Lists of designated notified/conformity assessment bodies for different regulatory schemes
  • Choosing the right conformity assessment body for your device including key considerations
  • Initial assessment: How to be sure you are ready
  • Stage 1 audits
  • Stage 2 audits
  • Remote audits - best practice
  • Surveillance audits
  • Renewal/recertification audits
  • Unannounced audits
  • Dealing with findings from Notified Bodies
  • Conformity assessment body etiquette
  • Where to go when things go wrong
The course is designed with European Regulatory frameworks in mind, including CE marking under EU MDR and IVDR, UK MDR 2002, but is also relevant to manufacturers who deal with other assessment bodies further afield, or who employ the services of the certification body for the provision of voluntary certification such as ISO 13485:2016 certification. If your device or QMS needs to undergo assessment by a certification, Notified or Approved Body, then this course will be of benefit.

This half day, online course, consists of a mixture of instructor led learning/lectures as well as group discussion/case studies.

Course price includes:
Provision of electronic pdf copies of course slides
Listing of candidate on MedRAS Assurance register for Notified Body interactions training completion


Course price includes:
  • Provision of electronic pdf copies of course slides
  • Electronic certificate of course completion
  • Listing of candidate on MedRAS Assurance register for Notified Body interactions training completion
Get in touch with our team

07974287070
Office@medras.co.uk
https://www.medras.co.uk/contact-us
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* Based on residence in United Kingdom. Tax rates for other countries will be calculated at the checkout. Price exclusive of tax: £300.00.