Design and Architecture of connected Medical Devices, including devices connecting with the cloud, apps, or both

Expertise and guidance for selecting qualified R&D design firms as well as contract manufacturers, insuring that your goals and requirements are explicit and clear, and help with monitoring their progress and deliverables

Ensuring your device, app, or cloud based device is architected for a least-burdensome regulatory pathway, which is especially important given the recent changes from the FDA and EU for mobile medical apps, cybersecurity and privacy, Software as a Medical Device and Medical Device Data Systems

Compliance with HIPAA and GDPR                                                                                                                                                                               .

Valuation of a Medical Device startup from the point of view of VCs, companies contemplating an acquisition or the startup itself

Guidance on multi-regional development, such as teams located in different countries or products that must fulfill needs for disparate countries