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Medical Devices

Regulatory Guidance

Medical Devices go through a rigorous development process, and are required to comply with quality system and product standards.

Medical devices are brought to market after a strict registration process which may vary from country to country.

Understanding the regulatory strategy early, as well as the applicable standards, results in valuable cost and time savings.

Our team of experienced QA/RA experts can guide your company throughout the implementation of the quality system, compliance with ISO 13485 and international registrations such as CE marking and FDA submissions.

We also provide assistance with AMAR registration.

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