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 (GHTF), it has quickly become the model standard for the medical industry.
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
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!
Additional Benefits of ISO 13485 certification:
- Increased Efficiency
- Cost Savings
- More Effective Risk Management and Quality Assurance
- Improved ability to respond to Customer Requirements
Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:
- Access to markets that recognize or require the certification including Canada and Europe.
- Reduce operational costs by highlighting process deficiencies and improving efficiency
- Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
- Proven commitment to quality through an internationally recognized standard
- Adds transparency to the way complaints, surveillance or product recalls are handled
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification
- Outline how to review and improve processes across your organization
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices
- Meet regulatory requirements and customer expectations