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?
- Basic knowledge of medical device manufacturing, design and marketing with a detailed understanding of quality management systems
- Ideally to have attended LR’s Introduction to the Medical Deice Regulation (MDR) prior to attending this training course.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.
Training from LR
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Certification with Exemplar Global
For an additional $99 USD you can also obtain an Exemplar Global Course Certification for your course.
What are the advantages of adding the Exemplar Global Certification?
With the additional Exemplar Global Course Certification, you will get access to:
- The Exemplar Global Work Style Behavioural Assessment
- One-Year Graduate Certification
- Use of Exemplar Global’s brands and logo to promote your certification
- Access to Exemplar Global Webinars and Online events
- Access to Exemplar Global online resources, including Auditor OnLine and regular Job Board notifications
- Access to the social community of graduates
- An innovative, continual learning environment for learners and graduates
- Ongoing support for an entrepreneurial career track for graduates and learners
How to add Exemplar Global Certification to your training course?
If you're booking online, you can add the option of Exemplar Global before you proceed to checkout or contact our team directly.
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