ISO 14971 Risk Management – Two day program - DUBLIN
August 27 and 28th 2020
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.
Course Objectives (Summary)
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.
Delivered by MedTech Industry Experts
As places are limited, book early to avoid disappointment.
All Dublin courses are to be held in the Louis Fitzgerald Hotel, 1A Naas Road, Newlands Cross, Dublin 22, D22 X5N7.
Please check here for other locations and dates.
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.
Need a quote for in-house training email firstname.lastname@example.org 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.
Purchase By Bank Transfer
Please select 'Add to Basket' and proceed to Check Out. At the Checkout select Bank Transfer.
Your order confirmation email will contain an order number please reference this order number when submitting your BAC's payment. The Order is on-hold until we confirm that payment has been received.
Our bank details
Irish Quality Centre:
Bank: Ulster Bank
Account number: 12670866
Sort code: 986280
IBAN: IE24 ULSB 9862 8012 670866
Purchase by PO
If you wish to pay using a Purchase Order please select Buy Now and proceed to Check Out. At the Checkout select Bank Transfer. You will recieve and email confirmation requesting your PO number be forwarded to email@example.com along with the Order Number referenced in the email.
An invoice will be sent to the billing address you submitted referencing the PO number you have submitted. The Order is on-hold until we confirm that the official PO Number has been received.
Pay by Credit Card
Please select ADD TO BASKET and proceed to Check Out.