“Demonstrate your ability to supply medical devices through
Quality Management System for Medical Devices – ISO 13485”

ISO 13485 is an ISO standard, published in 2016, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.

ISO 13485 is generally harmonized with ISO 9001. A vital difference is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Some of the additional requirements to ISO 9001 requirements relate to:-

1. Risk Management,
2. Design Control,
3. environmental controls,
4. Inspection, special processes (e.g. software validation),
5. traceability, record retention, and
6. regulatory actions (such as vigilance),
7. ISO 13485:2016 has been harmonised against the medical device directives, Active Implantable Medical Devises Directive, In Vitro Diagnostic Directive

This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.
Formal certification of quality management system, specifically for medical devices, to ISO 13485:2016 proves advantageous, for medical companies which export their products to the global market.

1. In the European Union, the fulfillment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices.
2. Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 by an accredited certification body.

Who Can Go For ISO 13485 Certification?

1. Companies who design, manufacture, distribute, install and service medical devices for the European and World markets.
2. Companies who manufacture OEM products which are sold under other company names.
3. Companies who design and/or manufacture medical device components or raw materials for the medical device market.
4. Companies selling, installing or servicing medical devices.
5. Consultants providing design services to the medical device market.
6. Companies providing services to the medical device market such as sterilization, cleaning, testing, etc.

To Know more on

1. What is medical device
2. Scope of Consulting
3. Activity Plan

Request a Guideline Document….

Benefits
ISO 13485 implementation leads to:-

1. Conformance to Legal and Regulatory Requirements
2. POLICIES & OBJECTIVES set by ‘top management’
3. Recognition by regulators around the world of ISO 13485:2016 as a good basis for addressing medical device design and manufacturing regulatory requirements
4. Controlled consistency of manufactured products
5. Managed productivity and efficiency, controlling costs
6. Competitive advantage and increased marketing and sales opportunities.
7. Improved customer perception of the organization’s image, culture and performance.
8. improved internal and external Communications
9. greater understanding of the organization’s processes
10. clear responsibilities and authorities agreed for all staff
11. improved use of time and resources
12. reduced wastage
13. greater consistency and traceability of products and services
14. Customer Confidence, Satisfaction and TRUST
15. Level of Assurance in Organizational QUALITY
16. Organizational PROFITABILITY
17. Ability to Differentiate Organization for Competitive Advantage
18. Organizational Credibility & Reputation

Training
Niall offer’s a customized training programme on ISO 13485:2016 for

1. ISO 13485 – Awareness on implementation and documentation requirements
2. ISO 13485 – Internal Auditor training