Two Day Risk Management training for Medical Devices– ISO 14971
The requirements for Product Risk Management as it pertains to all stages of a Medical Device Lifecycle is outlined in ISO 14971. The emphasis on the Risk Management process extends from Conformity and Compliance Assessments to assurances that Outsourced Processes, including Suppliers are thoroughly, adequately and appropriately audited with a Risk-based approach.
Who should Attend:
All personnel involved in areas relating to Quality, Production, Engineering, Supplier and Outsourced Process Management should be conversant with these requirements to provide assurance of Competency in Medical Device Product Risk Management.
This intensive course will evaluate and focus on the requirements of the ISO 14971 in detail and will demonstrate Risk Management practices that reflect best in class practices..
Delivered by MedTech Industry Experts
Describe the purpose of a Risk Management system and explain the Risk Management Process elements.
Explain the purpose, content and interrelationship of ISO 14971, ISO 13485, 21CFR820, MDSAP and EU MDR.
Interpret requirements of ISO 14971.
Define risk management.
Describe most frequently used risk assessment tool.
Define basic risk management terms.
Identify risk management responsibilities.
Describe the benefits of risk management.
During the 2 days participants will acquire knowledge and skills to implement an effective Risk Management system in conformance to ISO 14971. Risk Management, similar to any other system, evolves over time within a company as Knowledge grows and frequent reviews are conducted. Hence, the best place to practice and extend your experience is in reviewing one’s current system, conduct a gap analysis and determine if current established requirements are sufficient to meet applicable regulatory requirements.
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