ISO 13485 Certification

Quality management systems for medical devices.Medical Devices – Quality Management System (ISO 13485).

ISO 13485:2016 is the internationally accepted quality management standard for medical device industry organizations. It offers a framework which can be applied consistently by organisations to ensure they are able to continually fulfill customer expectations and meet regulatory requirements for medical devices.

What is ISO 13485?

Medical devices have demanding quality and regulatory requirements due to their performance and the impact it may have on patient and user safety. The ISO 13485 Medical Devices – Quality Management System assists organizations in implementing controlled processes to control aspects of design and development, production, purchasing, installation and servicing, documentation, risk management and monitoring product performance.

The standard is suitable for organizations involved in the design, manufacture, installation and servicing of medical devices and related services. It may also be applicable to suppliers and other entities involved in the medical device supply chain.

Why is ISO 13485 Important?

A medical device company can use an ISO 13485 Quality Management System to add some uniformity to processes and improve quality control of products. Regulatory requirements, risk management and process controls are emphasized in the standard.

Here are some noteworthy advantages:

• Improved management of the manufacturing and processes of medical devices
• Increased risk management and product safety
• Earning more trust from customers and business partners.Building more trust with customers and business partners.
• Help in complying with relevant regulations
• Quality of product description and consistency of product quality
• Enhanced readiness for regulatory and certification tests
• Assistance for market access and export to international markets
• ISO 13485 Certification Support from ISPL CMMI

At ISPL CMMI, we assist organisations in comprehending the demands of relevant management system standards and get their processes ready for assessment. We can approach this by gaining an understanding of the existing practices, identifying gaps, enhancing documentation and supporting implementation.

Intercontinental Systemcert Pvt. Ltd. (ISPL) has the experience in Management System Certification and the quality services related to it, giving professional guidance to organizations based on their operational needs.

Medical devices are manufactured, designed, installed or serviced by your organisation and ISO 13485 can give you a solid base for managing quality and regulatory requirements. Talk to ISPL CMMI about your ISO 13485 needs.