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 and Support
Support to determine necessary actions to secure product compliance, clearly identifying the points that can raise regulatory issues currently and down the road
Quality Management System
Implementation of Quality Management Systems namely concerning ISO 13485. Provision of services of Internal Audits
Medical Device Engineering
Support a development and maintenance of your device according to the best medical device engineering practices
Regulatory Documents and Submission Support
Support in creating and maintaining accurate, and compliant documentation for your Medical Device. Our Regulatory Submission services reduces the hassle of gaining regulatory approvals. Includes also Gap Assessment of your Documentation
Testing and Development Expert Services (Network-Based)
Network-based support for comprehensive Testing and Expert services to ensure the safety and effectiveness of your healthcare products
Training Academy
Training Focused on Regulatory Requirements of Medical Software, Quality Management System and Cybersecurity and Information Security Compliance
Cybersecurity and Information Security Compliance
Cybersecurity and Information Security Compliance
Comprehensive support that combines Cybersecurity expertise with compliance frameworks such as GDPR and ISO 27001
