Medical products have a direct connection to patient’s health.
In order to minimise the risk to the patient and ensure medical devices act in the way they are intended, it is essential that their design and manufacture be carried out to ensure they are safe and fit for use.
An essential component in the process is the assessment of the associated risks with a device and the management of these risks
Upon completion of this course, participants will have gained an understanding and knowledge of:
The regulations pertaining to risk management
Find out how ISO 14971:2000 fits with both the European CE Marking Regulations and FDA Regulatory requirements
Understand the business importance of using ISO 14971:2000
Learn how to use the standard in practice
Course Contents:
Risk Management
Why Risk Manage
Understand the need for risk management.
Understand the regulations pertaining to risk management
Introduction to ISO 14971- Risk Management (Medical Devices)
Structure of the standard – Medical Devices
Requirements of the standard
Contents and purpose of each section
Correspondence to and differences between ISO 9001:2000
CE marking implications
The Process
Risk Management Process
Understanding the characteristics related to devices
Identifying possible hazards.
Estimating the associated risk.
Review & reduction of risk.
Risk Management/Assessment Techniques
Risk Management using FMEA
Risk Management using FMECA
Risk Management using Fault Tree Analysis
Audit Exercise using the standard
Attendees will break into groups and carry out an FMEA of specific areas
Afterwards the groups will convene to share experience.
conclusions
Responding to an Audit
Review
Summary & Review
Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee. |
