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Quality Management Systems for Medical Devices
ISO 13485 is an international standard for Quality Management Systems specifically designed for the manufacturer of medical devices and can also be used for the development production, installation and servicing of medical devices.
This standard helps an organization to explain its ability to provide medical devices, related services and commitment to quality that continuously meet customer requirements and regulatory requirements applicable to medical devices.
The primary objective of ISO 13485 (Medical Devices) is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Advantage of ISO 13485
- Improved stakeholders’ relationships.
- Improved risk management.
- Proven business credentials.
- Ability to win more business.
- Legal compliance.
More Specific Advantage
- Increases customer satisfaction.
- Reduce operating costs.
- Keeps the continuity of the effectiveness of the ongoing system.