ISO 13485:2016 Transition

OMEDtech can help your company transition to ISO 13485:2016 in time for the February 2019 deadline.

ISO 13485:2016 Transition

Our services can help to complete the transition as you update your QMS.

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ISO 9001:2015 Transition

We can provide support for the ISO 9001:2015 transition for the upcoming deadline of September 2018.

ISO 9001:2015 Transition

Let OMEDtech help you with the transition today!

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Quality Systems

Quality Systems

Regulatory

Regulatory

Auditing

Auditing

Consulting

Consulting

Medical Device Quality Management Systems

We have a proven track record of successfully helping companies develop robust systems, achieving compliance and certification of their Quality Management Systems.

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Auditing Services

Regulatory Compliance

OMEDtech simplifies the quality management system development process with a proven documentation system that is customized for your company’s specific needs.

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Auditing

Maintaining schedules for internal audits and supplier qualifications can be stressful and expensive. Our experienced auditors help your team measure and manage QMS compliance.

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Medical Device Consulting

OMEDtech works with companies wanting to enter the international market via CE marking as well as International companies seeking to market in the US via FDA clearance/approval….

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