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


Guide the development of a compliant product


Implement Quality Management Systems


Provide continuous product and strategy update


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


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