Medical Devices - ISO 13485
ISO 13485 is the International Standard for Medical Devices

The ISO 13485 Registration is a proof of Quality Management System. It compliance to the standard for any farm involved in the Medical Device industry. This approach is not only followed by Medical Device products but also supporting farm. Such as Sub contractors, Suppliers, European Authorized reps.

ISO 13485 is the main Quality Management System (QMS) standard for medical devices, although several countries have their own set of regulations. As an example, the United States plans to harmonize the Food and Drug management (FDA) requirements for medical devices with ISO 13485. The scope of the QMS is to tailored for an organization, in Section 7. The current version is ISO 13485:2016, which published in March 2016.

Note that ISO 13485:2016 expands the profile of companies and Farm to which the standard can apply: Organizations involved in one or several stages of a Medical Device Life cycle or a Supplier or other External Parties providing such organizations

Need of ISO 13485:2016 (MDQMS)

The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems.
Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.
ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry.
Companies are using compliance to this standard to obtain the certification of their Quality Management System. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.
The latest survey conducted by the International Organization for Standardization (ISO) shows that in 2015, the number of ISO 13485 certificates issued worldwide was 26255.

The benefits of management systems certification

Your management system’s conformity with ISO 9001, ISO 13485, ISO 14971, or ISO 14001 can help your company open doors to untapped domestic and international business opportunities, and reap the benefits of:

Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence. Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.