INTRODUCTION FOR UNDERSTANDING OF REQUIREMENTS OF THE MEDICAL DEVICE REGULATION 2017/745 (MDR)
Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as well as manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).
Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The new scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our one-day seminar, you will gain a compact overview to align your company with the new requirements of the Medical Device Regulation (MDR).
LEARNING OBJECTIVE
The training provides:
- Overview of the FDA and intention of the 21 CFR Part 820
- The requirements of 21 CFR Part 820 and other relevant Parts such as Part 11, Part 803 and Part 821
- Working knowledge in application of the requirements
- Preparation and host an FDA inspection
HOW YOU WILL BE BENEFIT
- Have a good understanding of the expectations of the EU MDR 2017/745
- Assist anyone who may involve in the implementation and execution of this Quality System Regulation
- To Develop your knowledge of how the requirements of EU MDR 2017 / 745 are established and help the organization to fulfil the regulatory requirements
- Feel more confident about an FDA inspection
WHO SHOULD ATTEND
This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales. Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.
COURSE SOLUTIONS
- This course can be run in-company around the world
- We can tailor the content to focus on your requirements.
- This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
- Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
- Delegate manuals and certificates of Attendance will be provided
COURSE CONTENTS
DAY 1
Module 1:
Overview of Medical Device Regulation (MDR)
- background, structure and contents
- roles & responsibilities
- Contents and Fundamentals of the Medical Device Regulation (MDR)
Module 2:
- Classification/Reclassification of Products
- Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
Module 3:
- Common Technical Specifications
Module 4:
- New Basic Requirements
- Content Requirements for Technical Documentation
- Post Market Surveillance
Q&A session
DAY 2
Module 5:
- Scrutiny Procedure
- Validity of Conformity Assessment and Certification, Transition Periods
- Requirements for Different Actors, e. g.:
- Manufacturers
- Importers
- EU Representatives
- Distributors and Service Partners
- Role of Contact Person for Regulatory Compliance
Module 6
- Eudamed Database
Module 7:
- UDI (Unique Device Identification)
Q & A session
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