We Partner with Digital Health Companies
to help bring medical device products to market
We help
Determine the appropriate regulatory submission requirements and strategies for new or modified products
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Guide the development of a compliant product
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Implement Quality Management Systems
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Provide continuous product and strategy update
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Give access to the top regulatory intelligence support
Our work leverages a global network of experts
that can support each technology and need of the companies we work with
Consultancy
Regulatory Strategy of your Medical Device
Support the Creation of Technical Documentation for Medical Device Certification
Implementation of Quality Management Systems
Training
Training Focused on Regulatory Requirements of Medical Device Software and Quality Management System
