Manager Regulatory Affairs – TÜV, intensive seminar (Module 1)
Registration of medical devices in Europe
The English speaking intensive seminar „Manager Regulatory Affairs – TÜV“ contains all contents for the qualification as „Manager Regulatory Affairs – TÜV“. You demonstrate your competence in the areas of European medical device law according to Medical Device Regulation (2017/745, MDR) and management systems for medical device manufacturers (ISO 13485) and are able to carr/y out approvals of medical devices in the European Economic Area. You are familiar with the regulatory requirements for clinical evaluation, risk management (ISO 14971) and the necessary contents of the technical documentation.
Vorteile | Advantages
- You will receive the high-quality training for Manager Regulatory Affairs - TÜV in the shortest possible time.
- You will gain an overview of all important parameters in the medical device industry.
- You will learn the regulatory requirements for European approval procedures for medical devices.
Inhalte | Content
- Basic course in medical device law – regulatory framework according to MDR
- Current regulatory framework for medical devices in Europe (2017/745, MDR)
- Classification of medical devices, conformity assessment procedures, CE marking
- General Basic safety and performance requirements, CE marking
- Technical Documentation
- Requirements and contents of the technical documentation
- Relevance for conformity assessment procedures, notified bodies and national authorities
- Technical documentation for OEM products
- Control and availability of documents, examples of selected documents
- Management systems for manufacturers
- Importance of ISO 13485, comparison to ISO 9001
- Structure, contents and application of ISO 13485
- Fokus: selected core processes
- Clinical evaluation of medical devices – Basic course
- Regulatory requirements and their implementation
- Contents of Clinical Evaluation Plan and Clinical Evaluation Report
- Interfaces to risk management
- Update of the clinical evaluation and interface to the post-market surveillance process
- Risk management and risk analysis for medical devices
- Requirements of ISO 14971 and their implementation
- Risk management plan, risk analysis, risk evaluation, risk control, risk management report
- Practical implementation workshop
Zielgruppe | Target group
- Newcomers in the medical device industry
- Expert and executive personnel seeking to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
- Consultants in the medical device industry
Hinweis | Note
This seminar is part of a modular qualification and addresses internationally valid standards and can also be held abroad.
A book Medical Device Regulation (MDR) is included in the seminar price.
Duchführende Akademie | Executing Academy
Alle Online Termine dieser Veranstaltung werden von der TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainings gelten daher zusätzlich die Allgemeinen Geschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehen wir Ihnen gerne unter [email protected] zur Verfügung.