Product Description

ISO ****5 was established in ***3 as an international standard for the design, manufacture and distribution of medical devices. While compatible with the quality management standard ISO ***1, ISO ****5 requires proof of implementation and maintenance, but not continuous improvement.

 Becoming certified in the ISO ****5 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 ****5 certification you will be able to enter any major market around the world with one audit!
By becoming ISO ****5 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.

Additional Benefits of ISO ****5 certification:

• Increased Efficiency
• Cost Savings
• More Effective Risk Management and Quality Assurance
• Improved ability to respond to Customer Requirements

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