{"title":"Equip course No EQ004: MDR (EU) 2017\/745: An introduction","content":"<table><tbody><tr><td>The new European Medical Device regulation is here. This 1 day course will equip attendees with the information required to embark confidently on their MDR journey. This course is an extensive overview of key aspects of regulatory compliance in relation to the MDR and will cover the following considerations:<\/p><table><tbody><tr><td><ul><li>Background to EU Legislation<\/p><\/li><li>Background and introduction to MDR <\/p><\/li><li>Manufacturer obligations<\/p><\/li><li>The MDR Quality Management System<\/p><\/li><li>EU MDR conformity assessment<\/p><\/li><li>The MDR Declaration of Conformity<\/p><\/li><li>Technical Documentation<\/p><\/li><li>Unannounced audits<\/p><\/li><li>Significant change<\/p><\/li><li>Authorised representative obligations<\/p><\/li><li>Registration\/Eudamed<\/p><\/li><li>PRRC<\/p><\/li><li>Design change<\/p><\/li><li>Labelling \/ IFU<\/p><\/li><\/ul><\/td><td><ul><li><\/li><li>UDI implementation<\/p><\/li><li>Translation procedures<\/p><\/li><li>CE marking<\/p><\/li><li>Classification<\/p><\/li><li>PMS\/PMS Plan<\/p><\/li><li>PMCF<\/p><\/li><li>Vigilance<\/p><\/li><li>Recalls<\/p><\/li><li>The role of the Notified Body<\/p><\/li><li>Control of outsourced processes<\/p><\/li><li>Training considerations<\/p><\/li><\/ul><\/td><\/tr><\/tbody><\/table> Course price includes:<\/p><ul><li>Provision of electronic pdf copies of course slides<\/p><\/li><li>Listing of candidate on MedRAS Assurance register as auditable evidence of training completion<\/p><\/li><\/ul> <\/td><\/tr><tr><td>\n\nCourse dates: The course runs once per month: available dates below.<\/p><\/td><\/tr><tr><td> <\/td><\/tr><tr><td>Course location:  Online Via MS Teams: Please get in touch with us via the contact page to arrange bespoke group in person training.<\/p><\/td><\/tr><tr><td><\/p><\/td><\/tr><tr><td>Course price: \n\n\u00a3300 excluding vat per person\n\n<\/p><\/td><\/tr><tr><td><\/p><\/td><\/tr><tr><td><\/p><\/td><\/tr><tr><td>Course price includes:<\/p><ul><li>Provision of electronic pdf copies of course slides<\/p><\/li><li>Electronic certificate of course completion<\/p><\/li><li>Listing of candidate on MedRAS Assurance register as auditable evidence of training completion<\/p><\/li><\/ul><\/td><\/tr><\/tbody><\/table> <\/b>\n\n ","deleted":0,"featureImageAssetRef":4694460,"updated":{"date":"2024-02-26 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Equip course No EQ004: MDR (EU) 2017/745: An introduction

£ 360.00 incl. tax*

The new European Medical Device regulation is here. This 1 day course will equip attendees with the information required to embark confidently on their MDR journey. This course is an extensive overview of key aspects of regulatory compliance in relation to the MDR and will cover the following considerations:
Background to EU Legislation
Background and introduction to MDR

Manufacturer obligations
The MDR Quality Management System
EU MDR conformity assessment
The MDR Declaration of Conformity
Technical Documentation
Unannounced audits
Significant change
Authorised representative obligations
Registration/Eudamed
PRRC
Design change
Labelling / IFU
UDI implementation
Translation procedures
CE marking
Classification
PMS/PMS Plan
PMCF
Vigilance
Recalls
The role of the Notified Body
Control of outsourced processes
Training considerations

Course price includes:
Provision of electronic pdf copies of course slides
Listing of candidate on MedRAS Assurance register as auditable evidence of training completion

Course dates: The course runs once per month: available dates below.

Course location: Online Via MS Teams: Please get in touch with us via the contact page to arrange bespoke group in person training.
Course price: £300 excluding vat per person
Course price includes:
Provision of electronic pdf copies of course slides
Electronic certificate of course completion
Listing of candidate on MedRAS Assurance register as auditable evidence of training completion

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