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.
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.