ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.

ISO 13485 contains requirements that are essential for a organization operating at any tier in the medical device and pharmaceutical supply chain.

It is especially applicable to manufacturers that want to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers

The primary objective is to aid harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:
• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems


Applicable for:

Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.

Companies who manufacture OEM products, which are sold under other, company names

Companies who design and/or manufacture medical device components or raw materials for the medical device market

Companies selling, installing or servicing medical devices

Consultants providing design services to the medical device market.

Companies providing services to the medical device market such as sterilization, cleaning, testing, etc

ISO 13485 Benefits of Certification

For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements.

Since 2003 when ISO 13485 was first implemented and recognized by the Global Harmonization Task Force, it has quickly become the model standard for the medical industry.

By becoming certified in the ISO 13485 standard company will:

Increase the probability of making safe and effective medical devices
Meet regulatory requirements
Meet customer expectations
Help monitor the effectiveness of your supply chain

Additional Benefits of ISO 13485 certification:
Increased Efficiency
Cost Savings
More Effective Risk Management and Quality Assurance
Improved ability to respond to Customer Requirements