Regulatory Basics of Medical Devices in Europe
The workshop conveys basics of medical device regulations in Europa. It addresses the critical topics of classification and conformity assessment in accordance with EU directives and regulations.
Content:
- What is a medical device
- Applicable regulations in Europe (directives/regulation)
- National implementation
- Classification and conformity assessment
- Standards
- Jurisdiction in Germany
- Basics of quality management
- Post-market surveillance and vigilance
Duration: 1 day
Delivery Partner: Schrack & Partner
Location: online or on-site
Basics of Risk Management for Medical Devices
The workshop conveys basics of risk management for medical devices and the procedures for performing risk analyses in accordance with legal and normative requirements. It is based on the EU regulation 2017/745 and the EN ISO 14971 standard. The workshop details drawing up and implementing a comprehensive risk management process.
Content:
- Legal requirements for risk management
- Structure and content of EN ISO 14971
- Structure of the risk management file
- Preparing a risk management plan
- Hazards and their assessment
- Risk analysis and mitigation
- Risk management report
- Risk management during the product life cycle
- Integration into the quality management system
Duration: 1 day
Delivery Partner: Schrack & Partner
Location: online or on-site
Medical Device Design and Development (Focus: Software)
The workshop conveys legal and regulatory requirements for the design and development process. It takes into account the requirements of EN ISO 13485:2016 and regulation (EU) 2017/745. The implementation is discussed using the concrete procedure for a design and development project with its phases and their documentation. Aspects of software life cycle (according to EN 62304), risk management (according to EN ISO 14971), and usability (according to EN 62366) are discussed.
Content:
- Legal and regulatory requriements for design and development of medical devices
- The design and development process and its phases
- Documentation requirements
- Software life cycle according to EN 62304
- Risk analysis and usability
- Design validation and clinical evaluation
- Change management
Duration: 1 day
Delivery Partner: Schrack & Partner
Location: online or on-site