Seminar / Workshop "Risk Management & ISO 14971"

Goals

Risk management is the linchpin of medical device law. In this workshop, you will learn to avoid risk management mistakes that can lead to problems in audits and delays in the "approval" of your medical devices.

Content:

• Regulatory Requirements
  You know the relevant standards, laws, directives, regulations and guidelines as well as their interaction.
• Risk acceptance
  You are able to determine acceptable and unacceptable risks for your medical device.
• Risk analysis
  You can apply risk analysis procedures such as PHA, FMEA and FTA and systematically identify hazards for your medical device.
• Risk control
  You know what approaches are available to manage the risks posed by your medical device and thereby maximize the safety of your patients.
• Risk management documentation and audit
  You are able to create an ISO 14971 compliant risk management file and know the typical findings in audits when creating the documents.
• Risk management in design controls and product life cycle
  You know how to integrate the activities of the risk management process into your development process and how to establish market surveillance in compliance with the law.
• Special considerations for software
  You have answers to software-specific questions on, for example, probability estimation, software security classes, and typical risks posed by software.

This seminar thus provides you not only with a comprehensive knowledge, but also with the skills to create and review the risk management files for your medical devices and to coordinate the activities related to risk management.

Agenda

The seminar lasts two days, with a focus on practical relevance. The lectures alternate with case studies and numerous exercises. We are happy to discuss your specific files and subject them to a "quick check" if desired.

Target group

The seminar is intended for persons involved in the development of medical devices in compliance with standards, in particular for 

• Risk managers
• Safety officers for medical devices, persons responsible for regulatory compliance
• Developers, system and software architects
• Project managers
• Responsibles for Regulatory Affairs and Quality Management

The seminar is also suitable for beginners and teaches (also) the basics of risk management. However, in the course of this intensive workshop, participants reach a higher advanced level and work on challenging tasks.

Question, Further Information, In-house Seminars

Do you have any questions or suggestions? Do you want to carry out the seminar as an inhouse seminar to tailor the topics to your individual needs? Contact us directly. We are looking forward to it!