Introduction
The requirements for Product Risk Management as it pertains to all stages of a Medical Device Lifecycle is outlined in ISO 14971. This 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. During the course participants will acquire knowledge and skills to implement an effective Risk Management system in conformance to ISO 14971. Risk Management, like 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.
Who should Attend:
All personnel involved in areas relating to: Product Development R&D Quality Production Manufacturing Procurement Engineering Supplier Management Outsourced Process Management should be conversant with these requirements to provide assurance of Competency in Medical Device Product Risk Management per Clause 4.3 of ISO 14971:2019 Join us for a 2 - day course that will build and enhance your competency on ISO 14971:2019.
This is an on-line course with an expert tutor that currently works in the Medical Device industry. DAY 1 and DAY 2 are interconnected, but independent.
Cancellations Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
DAY 1
This training will give you a strong foundation on the interconnectivity of Risk Management (RM) within the framework of both conformity and compliance.
All you wanted to know about ISO and Regulations pertaining to Medical Devices will be explained, and acronyms like MDSAP, EUMDR, ISO, NB and CE marking will no longer be a mystery. We will go through ISO 14971:2019 in detail and interpret the clauses. This day is most suitable for those who want the theory and the ‘what has changed’ in the new revision of ISO 14971:2019
Objectives:
• Describe the purpose of a risk management system and explain the process elements.
• Standards and Regulatory Requirements: Explain the purpose, content and interrelationship of ISO 14971, ISO 13485, 21CFR820, MDSAP and EU MDR.
• Interpret requirements of ISO 14971.
• Define Risk Management
• Identify Risk Management responsibilities
• Understand the Risk Management Lifecycle
DAY 2
This is the practical workshop where we execute what the Risk Management (RM) standard ISO 14971:2019 requires.
We will spend time showing you how to structure your RM file, when to do what and what all the language means.
By the end of the course, you will be able to execute RM and most importantly, Maintain a RM File (RMF).
This day is suitable for all those who will execute and be responsible for Risk Management activities.
Objectives:
• Practical work exercises on applying ISO 14971
• Understand the use of Product Safety Standards
• How to identify and document Harms, Hazards, and Hazardous situations
Top Level - How to conduct a Hazard Analysis
Top Level - How to perform Risk Control
Top Level – Risk Control Techniques
Top Level – Risk Review and PMS