ISO 13485
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of Medical Devices. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Benifits:
- Implementing a Quality Management System, in general, helps to motivate staff and provide a better definition of roles and key responsibilities.
- Implementing a Quality Management System specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements (compliance) and safety standards.
- Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted and corrected.
- Improvements can be developed on a systematic and monitored base, resulting in less waste, less inappropriate or rejected work, and fewer complaints.
- Provides a systematic approach to risk management.
- Systematic, smoother, transparent and documented handling of activities required by regulation such as post-marketing follow-up and surveillance, complaints handling, CAPA implementation, field actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.
- Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features.
- Help creating a systematic vision embracing the medical device lifecycle, medical device packaging, its labeling, its installation, its servicing, and its usability. This includes the information provided together with the medical devices, the commercial claims, the unspoken user expectations, the feedback from users or patients, the risks associated with use, the benefits brought to the single patient and to the Community, the costs and the disposal of the medical device.
Our Role:
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