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ISO 14971 Risk Management – Two day program -  Virtual Classroom Delivery  

May 22nd and May 29th 2020 Fully Booked! Next Date 21 & 28 August - contact for waiting list.  


Two Day Risk Management training for Medical Devices– ISO 14971 
Our 2 -day course ill certify you to competency on ISO 14971:2019. 
This is an on-line course with a tutor that currently works in the Medical Device industry. 
To ensure a completely positive learning experience we have now split the RM training days to allow individuals absorb Day 1 and to prepare for Day 2. 
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
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. 
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. 
Delivered by MedTech Industry Experts 
As places are limited, book early to avoid disappointment. 
Location: Virtual Classroom 
Please check here for other locations and dates. 
DAY 1 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 
• Describe the Benefits of Risk Management 
• Risk Management Lifecycle 
This day is particularly Ideal for those working in Induatry who want the theory and the ‘what has changed’ in the new revision of ISO 14971:2019 
DAY 2 Objectives: 
This is the practical workshop where we execute what the Risk Management 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 RMF. This day is particularly suitable for all those who will execute and be responsible for Risk Management activities. 
Activities include. 
Practical work exercises on applying ISO 14971 
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 
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. 
Those working in Induatry who want the theory and the ‘what has changed’ in the new revision of ISO 14971:2019 
Those who will execute and be responsible for Risk Management activities. 
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. 
Need a quote for in-house training email or phone +353 (0) 1-204 0646 
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge. 

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Our bank details 
Irish Quality Centre: 
Bank: Ulster Bank 
Account number: 12670866 
Sort code: 986280 
IBAN: IE24 ULSB 9862 8012 670866 

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