Industry Expert Learning Series HRDF SBL Claimable
Risk Management for Medical Devices (ISO14971:2007)
DURATION : Two (2) full days INTRODUCTION ISO 14971:2007 is the only international standard for risk management for medical devices used to demonstrate compliance with requirements of all regulated markets including the US FDA 21 CFR’s, the EU Directives for Medical Devices (MDD; AIMD; and IVDD), Malaysian Medical Device Act & Regulations, etc. The latest revision to ISO 14971 has also been implemented to address the increased emphasis on risk requirements that have been updated to Medical Device Regulations. This workshop provides a thorough introduction and interpretation of ISO 14971:2007 risk management, throughout the product lifecycle.
To understand that risk analysis is a regulatory requirement for all classes of medical device
To understand risk management versus risk analysis
To understand the interaction with ISO 13425:2003
To address fundamental differences between ISO 14971:2007 and EN ISO 14971:2012
To be able to plan ISO 14971 strategy appropriate to scope & responsibilities of Legal Manufacturer –v- Contract Manufacturer
To be able to construct a basic risk management plan
Use of the ISO 14971:2007 annexes in conducting a risk analysis
Identification of key quality management system procedures which need to link to risk management
Recognition that FMEA (Failure Mode and Effects Analysis) alone is not medical device risk analysis
The requirements and structure of a Risk Management File
Regulatory requirements for medical device risk management
Content and interpretation of ISO 14971:2007
Alignment of ISO 14971:2007 to ISO 13485:2003
What is a risk management plan?
How to conduct a risk analysis
What is risk control?
Requirements for a Risk to Benefit evaluation
The risk management process within the product lifecycle
Regulatory Affairs Managers
Auditors of Medical Device manufacturing firms (internal and external)
Cross functional team members of implementation project
Risk Management Team members
PRE-REQUISITES Basic understanding of the Medical Devices Regulations, ISO 13485 2003 and basic understanding of Design and Development Control is preferred. Previous knowledge of ISO 14971:2007 not required.
iNTERESTED TO FIND OUT MORE? For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347