ISO 13485 Certification

Qualify your medical devices with 13485 standard

ISO 13485 Certification is one of the most trusted quality management system for designing and manufacture of medical devices. It is tailored to the standards and quality system expectations and regulatory requirements. This standard is generally harmonized with ISO 9001 while remaining a stand-alone document. ISO 13485 requires the business to demonstrate the quality system that is effectively implemented and maintained.

This certification system allows you to control in the work environment ensuring product safety. During product development it focuses on risk management activities and design control activities. The main goal of this certification is to facilitate harmonized medical device regulatory requirements for quality management systems.

We will help you in complete documentation and implementation of the system that helps you in fulfilling specific requirements for inspection of implantable devices. Fulfills specific requirements for effective verification of corrective actions.

Go for ISO 13485 Quality management system for your medical devices and bring assurance and confidence to your organisation.