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Responsible for regulatory compliance?

Implementation of the Medical Device Regulation (MDR).

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Introduction

A two-day course providing details of the new MDR which replaces the existing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC).

This course is primarily intended for enterprises who already manufacture products against the existing MDD. It can be delivered as either a public or in-house event but is seen as particularly attractive as in-company where the content can be tailored to suit the needs of the organization.

Who should attend?

Individuals responsible for regulatory compliance working in an organization involved in any aspects of medical device manufacturing, designing, marketing or the supply chain.

What will you learn?

  • The requirements of EU 2017/745
  • The European regulation CE marking approach for medical devices including its legal and operational basis
  • The structure and scope of the MDR including classification and conformity routes
  • The safety and performance requirements checklist applicable to CE market
  • To create technical documentation to support the product throughout its life cycle
  • The level of clinical evidence necessary to demonstrate conformity
  • To develop a robust and proactive post market surveillance system under the new MDR including vigilance reporting and monitoring
  • The regulatory significance of a robust quality management and risk management system
  • To gather the business impacts of the regulation and start to develop a transition plan.

What do you need to prepare?

What's included?

  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

Course length

Two days.

There are no dates available for this course at the moment. Get in touch with our team to request booking on the next date.

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