หลักสูตร ISO 14971 Medical Risk Management
- รายละเอียด
- ฮิต: 7199
ISO 14971 Medical Risk Management
Course Description |
Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers. The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance |
Course Description |
Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers. The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance |
Course Benefits |
$1· Be confident your medical devices are ISO 13485 compliant $1· Ensure compliance continues throughout product lifecycle $1· Gain competitive advantage with ISO 13485 accreditation $1· Increase market access and customer confidence $1· Encourage professional development and build risk awareness. |
Learning Objectives |
Upon completion of this training, participants will be able to: $1· Understand the importance and purpose of ISO 13485 $1· Identify the links between ISO 13485 and ISO 14971 $1· Learn how risk management applies to the product lifecycle $1· Define risk management terminology and objectives $1· Outline and lead the ISO 13485 risk management process $1· Gain CPD points and professional recognition |
Intended Audience |
$1· Those working in regulation, quality, development and design $1· Those working in manufacturing and marketing $1· Those responsible for management system strategy decisions $1· Internal auditors |
Course Duration |
2 day |
Prerequisites |
There are no formal prerequisites, but it is recommended that you have a good understanding of your organization and its operations. |
Further Information |
A certificate of attendance is awarded to participants on this course. |
Agenda
Day 1
Time |
Topic |
09.00 |
Welcome and Introductions |
Course Aims, Objectives and Structure |
|
Risk management terms and definitions |
|
Regulatory requirements (MDD, AIMDD, IVDD) |
|
Risk management and the QMS |
|
EN ISO 14971: Overview of structure and contents |
|
Risk management process: overview |
|
Risk management techniques: Brief overview |
|
17.00 |
Summary |
Day 2
Time |
Topic |
09.00 |
Day 1 Review |
Risk management process: Step by step |
|
Risk analysis |
|
Risk evaluation |
|
Risk control |
|
Evaluation of overall residual risk |
|
Risk management report |
|
Production and post-production information |
|
Summary and questions |
|
17.00 |
Close course |
Two short breaks will be taken at suitably convenient times in the morning and afternoon. Forty five minutes will be given for a lunch break. Additional breaks may be taken as long as agreed by delegates and tutor, and all learning objectives are met.