This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR). The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers.
You will learn all the requirements needed for conformity assessment, how to fulfil technical documents and how to plan post-market activities required by the MDR. By the end of the course you will be able to put all this knowledge into working practice in your organization.
How will I benefit?
- Comprehensive understanding of the European medical devices regulation
- Support other people and partner organizations affected by MDR
- Organize required documentation
Who should attend?
The course is especially suitable for:
- RA, QM, and QA professionals who need to implement the MDR
- Anyone concerned with certification or active in projects for CE-marking
- Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
Please note: This course will not cover implementation for In Vitro Diagnostics or concentrate on devices with specific requirements.
What will I learn?
- Develop a strategy for regulatory compliance as stipulated by MDR
- Implement requirements concerning the following steps for Conformity Assessment:
- Scope and applicability of MDR
- EU risk classification criteria for medical devices to determine “Risk Class”
- General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of standards
- Conformity assessment routes and their application based on risk class
- Self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
- ‘Declaration of Conformity’ and CE marking
- Fulfil Technical Documentation requirements, e.g. in
- Putting together ‘Technical Documentation’
- Necessary control of outsourced activities and processes and roles of external partners (e.g. supplying and commercial)
- Instantiate the importance and role of clinical data
- Risk management, process validation and their regulatory significance
- Drawing up Instruction For Use, label and other information supplied with the device
- Consistency and validity of information and electronic data management
- Plan post-market activities required by MDR with respect to:
- Risk Management and related planning
- Post-Market Surveillance and Post-Market Follow-Up (PMCF)
- Periodic reports, Vigilance, ad-hoc reporting
- Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
- Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
- Regulatory relevance of change control to QMS, design and manufacturing
- Extent of readiness for audits/reviews/assessment
- Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking
What is included?
- A loan copy of the standard for use during the course
- Gain 24 CPD points on completion and comprehensive training notes
Prior knowledge and learning
- You must have a good understanding of the requirements in the MDR, if you do not, we highly recommend attending the MDR Requirements course.
You should also have either:
- Experience with, or basic knowledge of quality management systems for the medical device industry
- A good understanding of European medical devices legislation
- Some experience in pre or post market activities within the EU
