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Our Services

We offer managed services to support market approval of your medical device. Whether you need the whole package to get and maintain your product on the market, or only need help with a few bits and pieces, we tailor our services to fit your current needs!

QMS Setup
ISO 13485 & FDA Certification
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CE Mark and Regulatory Submission
Technical Documentation
Clinical Evaluation, Software Validation, Usability Evaluation, Risk Management.
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Data Privacy
Setting up of management systems to comply with the GDPR as well as incorporation into existing QMS.
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Testimonials

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