Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• European Authorized Representation
Our courses are most often conducted by the experts involved in the development of the standard. The course also focus on practical issues what manufacturers and suppliers need or should do based on our hands-on experience from the medical device industry.
Risk Management for Medical Devices
An efficient system for product risk management is central for a medical device company. This basic course in risk management will give you a complete walk-through of risk management as applied to medical devices and in-vitro medical devices.
You will learn about key risk management concepts and get an overview of the process steps involved, according to the new ISO 14971:2019. You will also learn how risk management practices should be applied throughout a product’s entire life cycle and how it relates to other processes within a quality management system.
We will highlight specific regulatory requirements that apply to risk management and give you an insight into the increased regulatory focus on risk management in MDR and IVDR.
With hands-on exercises, group discussions and examples, this course will provide the knowledge and skills you need to understand and perform each step of the risk management process. The practical part of the course includes an overview of the most common tools used for risk analysis, best practices for documenting results, and how to ensure traceability.
- Requirements according to ISO 14971:2019
- Regulatory compliance requirements according to MDR/IVDR
- Key risk management concepts and definitions
- Risk management process (risk analysis, risk evaluation, risk control, overall residual risk evaluation, benefit–risk analysis, risk management review)
- Production and post-production activities
- Methods and tools for risk analysis
- Elements of risk management plan, report, file and traceability
- Integration of risk management into a product’s life cycle and quality management systems
The printed course material is in English.
Verbal presentations and discussions will be in Swedish or English depending on the participants.
After successfully completed course including a proficiency test participant will receive a certificate
- Personnel performing or participating in risk management activities for medical devices, who need to learn the basics of risk management.
- Personnel who need to refresh their basic knowledge within risk management.
Need of prior Knowledge/Experience
We recommend that participants are familiar with quality systems requirements for medical devices according to ISO 13485.
- To provide you with the knowledge and skills you need to be able to understand and perform each step of the risk management process.
- To provide you with the tools needed for establishing and maintaining a well working risk management process, integrating it with your organization’s quality management system.
QAdvis consultant/s based on the specialist competence required for each course
Please contact us for a discussion, content specification or proposal at firstname.lastname@example.org