The requirements contained in ISO 14971 provide medical device manufacturers and suppliers with a framework to manage the risks associated with medical devices. ISO 14971 covers a vast array of medical product types and technical disciplines to address specific classes of risk, such as usability, software, and biocompatibility.
Regulatory and risk practitioners often benefit from guidance and insight gained through structured learning sessions on risk management principles and applying those principles to their unique device types. Our risk management training courses are intended to provide a deep understanding of risk management principles, tools, and techniques. Course offerings include specialized technical disciplines in the context of a risk management framework, noting that many regulators and requirements call for “risk-based” approaches. Custom courses are also available for individual product types, which can include case studies built on client-specific applications.
ISO 14971 medical device risk management training for a fixed fee
Our fee for training is based on a set fee plus expenses, regardless of how many employees attend. This provides a great value for companies that need to train three or more employees at one time. On-site training gives your employees the opportunity to ask questions (something they cannot do with public or online classes) and helps verify that every employee is receiving consistent information.
What your team will learn in the core ISO 14971 training course
This is a comprehensive course covering all required elements of ISO 14971. Case studies are used to reinforce learning, where participants follow the full risk management lifecycle processes for a fictional company as they apply their processes to a product and learn from field experience. Participants will also gain an understanding of how and where risk management requirements link directly to QMS requirements.
ISO 14971 course topics include:
- General Overview of Risk Management
- The Clauses of ISO 14971 and how they relate to your specific devices
- Management responsibilities
- Risk Assessment
- Tools for risk management - and understanding how and when in the lifecycle to use them
- Preliminary Hazard Analysis
- Fault Tree Analysis
- Failure Mode and Effects Analysis
- Risk Mitigation Approaches
- Benefit/Risk Analyses
- Residual Risk Analysis
- Post-Market Surveillance
- Post-Market Clinical Follow Up
- CAPAs and NCRs
OPTIONAL: This ISO 14971 training can be extended to two or more days depending on how in-depth you want the subject coverage to be. This may include fully customized material, incorporating products and/or case studies based on your organization's unique product types. Please inquire for options, availability, and pricing.
Ask us about group ISO 14971 training for your company
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.