ISO 13485:2016

IMPORTANCE OF MEDICAL DEVICE CERTIFICATION IN YOUR BUSINESS

ISO 13485:2016

ISO 13485 is an international standard specifically designed for the medical device industry, outlining requirements for a quality management system (QMS)

Benefits of  Medical Device Certification

• Industry Recognition

• Increases customer confidence and international acceptance

• Improved Processes and Efficiency

• Global Market Access

• Compliance with ISO 13485 helps mitigate legal liabilities by demonstrating adherence to industry standards, potentially reducing the risk of legal issues related to product quality and safety.

• Supply Chain Compatibility

• Continuous Improvement Culture

• Attracts investment, enhances brand reputation and removes barriers to trade