EN ISO 14971:2000 RISK MANAGEMENT FOR MEDICAL
DEVICES
EN ISO 14971:2000 – risk management
for medical devices includes risk analysis, evaluation, control
and post production information.
Do not confuse with EN ISO 14971-1:1998 which is replaced
by this standard.
The risk analysis element of EN 1441 is retained within the new
standard.
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Intended Use
Hazard Identification
Risk Estimation
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- Options Analysis
- Implementation
- Residual risk evaluation & acceptance
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| POST PRODUCTION
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- Post-production Experience
- Review of Risk Man Experience
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All recorded in the |
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THE EN ISO 14971 PROCESS IS CONTINUOUS
For more information – read the standard and should you still
require assistance contact David
Baker
For further information and free advice please complete our
form
tel: +44 (0) 1380 848170 fax: +44
(0) 1380 840152 david.baker@riskman.info
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