ISO 13485 Medical Device Quality Management Certification Support

Overview

ISO 13485 sets the requirements for a quality management system for medical devices, covering design, production, storage, distribution, installation and servicing. The current edition is ISO 13485:2016.

In India, medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. Their Fifth Schedule sets quality management requirements that closely follow ISO 13485, so a certified ISO 13485 system supports both the Indian licence and export registrations.

Who needs it

• Medical device manufacturers in every risk class.
• Contract manufacturers and component suppliers to device makers.
• Exporters to markets that expect ISO 13485, such as the EU.

Process

1. Gap analysis against ISO 13485 and the Medical Devices Rules.
2. Quality manual and procedures, including design controls and risk management.
3. Device and technical files, traceability and supplier controls.
4. Complaint handling, vigilance and corrective and preventive action.
5. Training, internal audit and management review.
6. Certification audit in two stages by an accredited certification body.

How Aaditech helps

Many medical devices are also electrical equipment, so we bring our electrical testing and BIS experience to the device file. We help you choose a certification body accredited for medical devices.

Contact us to start with an ISO 13485 gap analysis.