ISO 13485

Medical Devices Quality Management Systems (MDQMS)

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The ISO 13485 standard

Some regulators around the world directly require certification to ISO 13485. While this is not currently a requirement in the US, there is a US law that is similar in almost all aspects to ISO 13485, which is 21 CFR Part 820. Most US companies looking to send product outside of the US will also get ISO 13485 Certification.

Medical devices

Putting the regulatory considerations aside, implementing an ISO management system standard into your business represents good management practice, or in the case of medical devices “Good Manufacturing Practice [GMP].” By implementing ISO 13485, an organization becomes a better bet for their suppliers. Not only they have implemented important controls directly related to medical device manufacturing, but also they have provided efficiencies and effective management through:

Medical Devices
Expanded Market Access
Reduced Cost of Sales
Improved Performance
Boosted Company Credibility
Enhanced Customer Satisfaction
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