ISO 13485:2018
Introduction of ISO 13485 certification
This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard. With ISO 13485 certification you will be able to enter any major market around the world with one audit!
By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.
By becoming certified in the ISO 13485 standard your 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
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