Have you been left in a muddle surrounding the new ISO14971:2012?
Have you been faced with questions such as:
-Do all identified risks need to be eliminated?
-Do we need to rewrite all of our risk files?
Do not jump into the unknown alone, join Medilink West Midlands and Acclaim Biomedical as we take you through our full day Risk Management Course.
Risk Management has been a recurring theme over the last 20 years and the MedTech sector has matured. We have now reached a stage where risk management has become a central mechanism for systems operating within the sector.
Risk Management is a fundamental step for medical device manuafcturers to demonstrate compliance to the EU Medical Device Regulations, ensuring the safety of patients and users. Since the introduction of the ISO14971:2012 there has been a lot of confusion surrounding the implementation of the new standards, by medical device manufacturers.
This course will explore the requirements of ISO14971:2012, also touching upon what documentation is required.
Join this course to find out more about:
-The methodology in design and product management
-What considerations should be taken when running this process
-How this vital management information should be used, along with other critical elements
This course is aimed at Leading Risk Management Teams, Quality Regulators, Senior Managers and those that want to develop their knowledge in Risk Management.
This course will be delivered by Acclaim Biomedical Consulting, with over 20 years experience in Medical Devices, they are best placed to support and advise on the regulatory changes and the impact these will have on existing practice.
Course costs
Medilink Members: £165
Non-Medilink Members: £210
Your invoice will be forwarded to you on confirmation of your registration.
To find out more or register your place, please click here.