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ISO14971:2000
1. What is it about ?
Compliance with the Medical Devices Directive is mandatory for organizations supplying devices to the European market. ISO 13485:2003 is the best benchmark for quality and regulatory compliance. After July 2006 your certification to the current standard will expire. The new standard offers significant additional benefits to management, quality assurance and production. It is accepted as best practice by the 148 member countries of ISO representing all the world's major trading blocks including Europe, USA, Japan, Canada and Australia
As for the ISO 14791 is a replacement standard for EN1441. Although there are similarities between the two standards, ISO14971 actually asks manufacturers to meet extra requirements in building a complete process on risk management at all stages of the products lifecycles.
2. Why do you need it ?
Medical devices are one of the most highly regulated groups of products manufactured in the world. In all instances and countries with major markets, a complex series of regulatory requirements must be met prior to launching a device into the market.
Regulatory requirements are in place to assure the efficacy, safety and integrity of soon-to-be-marketed devices. However, these same regulations can also cause major headaches for companies struggling with the intricacies of meeting a myriad of requirements while trying to introduce a new device to multiple markets.
Risk management forms an essential part of technical documentation under the Medical Device Directive and In Vitro Diagnostic Device Directive. Manufacturers need to be able to demonstrate that they have carried out a satisfactory risk analysis in order to meet the requirements of these directives and gain a CE mark.
3. How will the course benefit you ?
During this one day seminar you will learn methods and strategies enabling you to use this harmonized standard to meet the essential requirements of these directives or regulatory requirement. You will gain a practical understanding of what risk management means, requirement of regulatory, compliances to standards and how to apply it to your business.
4. Who should take this course ?
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The Quality Management Representative (QMR) of the company.
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| Persons interested in gaining information and auditing skills critical to the new revision |
| Any person that is about to lead the effort for system implementation at the company |
| New members of the Management Representative Staff. |
| Persons interested in auditing as a professional |
| Those individuals that have inherited the reins for the QMS program at the company . |
5. Course location & date:
21 March 2006, Holiday Villa Subang, Selangor
6. Course tutors: Mr. Simon Lee Y.W.
7. Training agenda:
| Day 1: |
ISO 14971 |
Risk management |
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Why ISO 14971:2000?
Would it affect the ISO 13485:2003 certification status, if the company is not complying to ISO 14971:2000 requirements?
Terms and Definitions
General requirements of risk management
Risk analysis procedure and risk management
Risk estimation & its concept in risk management
Relevant type of analysis technique
Workshops
Questions to the participants
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8. Price: RM450/pax
9. Others:
HRDF Claimable (under SBL Scheme)
. Terms and conditions:
Your fee includes all course materials, lunch and refreshments. Accommodation or travel arrangements are not included.
If you are unable to attend a seminar for which you are registered:
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You can notify us and someone from your organisation might attend instead.
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If you cancel fourteen or more working days before the seminar date, DQS Certification (M) Sdn Bhd will refund 100% of any fees paid. However, if you cancel less than fourteen working days before the seminar date, DQS Certification (M) sdn Bhd will charge you a cancellation fee 50% of the fees paid.
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Should the event be cancelled by DQS Certification (M) Sdn Bhd, DQS Certification (M) Sdn Bhd liability shall be limited to the registration fees paid. DQS Certification (M) Sdn Bhd shall not be responsible for any consequential losses or other losses resulting from the cancellation of the seminar.
10. Registration Form
- Download it here (Right click and choose "Save Target As")
Should you have any doubt, please contact Ms. AG at
03 5633 2806 or email at agkoh@dqs.com.my
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