- ISO 13485 certification
- Easy to use ProActive ISO 13485 QMS
- Increased market access
- Increased efficiencies
ISO 13485 Medical Devices
ISO 13485:2016 is the international quality management standard for the design and manufacture of medical devices. The current ISO 13485 standard is largely based on ISO 9001.
Certification to ISO 13485 is particularly beneficial for organisations who manufacture medical devices. ISO 13485 is also relevant to companies in the supply chain and offering service support to manufacturers.
If your company exports medical devices and want to gain access to new markets, the standard provides a globally recognised quality system that may meet the market's requirements and save you valuable time and cost.
ISO 13485:2016 will provide you with a QMS that will:
ü Demonstrate your commitment to product quality
ü Improve quality control
ü Manage risks
ü Comply with any legal and regulatory requirements
ü Provide improved operational efficiency