ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices (e.g.in the US,Japan.Canada,EU).This standard includes requirements specific to this business sector and defines terms such as medical device,active medical device,active implanted medical device,sterile medical device,and many more.
ISO 13485 supports the reduction of unexpected risks for companies who construct,manufacture or use medical products and sevices,both during fabrication as well as for later use.It aims to increase reputation in the eyes of customers and authorities.
BENEFITS
• Evidence of adherence to legal and regulatory or contractual requirements.
• Minimize and manage risks.
• Emphasize competence.
• Error prevention instead of error correction.
• Improved performance quality.
• Customer and employee satisfaction.
• Transparency and clarity of internal processes.
• Time and cost savings.
• Realization of quality policy and company goals. |
