We are focused on medical device consulting services and solutions with global presence. We serve the companies in developed as well as emerging economies to improve the quality of health care services.

About Us

We are a European ISO 13485:2016 Certified company extending support with local presence in the Middle East and Asia.

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Medical Device

We are specialized in Medical Device Products and related challenges

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CE Mark

We can help and support getting your product ready for entering the EU and the UK market in compliance with all applicable requirements.

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Medical Device Sensibility

We Are a Team of Engineers and Subject Matter Experts with a long experience in the Medical Device field, this allow us to quickly find  the right approach for the projects, optimizing development basing on regulatory field, applicable international standards and previous experience with the biggest market leader companies.

Smart Approach to Documentation

We always try to design guidelines, procedures, quality system and documentation in the best way to make easy the update of the information and provide the best match with existing documents.

Network of Certified Suppliers

We develop our projects with the aid of our network of certified and reliable suppliers and partners. This allow us to provide always the best service and the needed expertise to guarantee the high quality level results we expect.


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Demystifying Swiss Authorized Representative Requirements

For the foreign manufacturers who want to place their products on the Swiss medical device market, it is necessary to appoint a Swiss Authorized Representative. However, an agreement must be ensured between the manufacturer and the Representative before the Representative’s appointment. Need of the Swiss Authorized Representative For the non-Swiss…
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Important Guidelines for MDSAP

The MDSAP (Medical Device Single Audit Program) is a three-year-long audit cycle. These cycles can be listed down as follows: The Initial Audit Cycle Partial Surveillance Audit Complete Re-audit The Initial Audit Cycle The initial audit cycle is the first year audit cycle and is also known as “Initial Certification…
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