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Review and Critique Regulatory Strategy of Diagnostic Software Platform
Cost: USD 180 | Time taken: 2 Week
The Challenge

MYndspan produces general wellness reports analyzing cognitive health and brain activity for clients. These reports do not provide medical advice and are not intended to be used to identify the presence or absence of a clinical diagnosis. They’re intended to be used for informational purposes only and can be used by medical professionals for diagnostic input. MYndspan had a regulatory overview document outlining the regulations that applied to them, which was used to guide their product design.The client was Caitlin Baltzer, co-founder and CFO at Myndspan. Caitlin wanted to have the document externally reviewed, critiqued and ensure it was in line with the latest updates. This required a freelancer that had expertise in several domains

How Kolabtree Helped

Upon posting the project, Caitlin received two bids within 8 hours, one from the USA and one from India. After conversations with both, she eventually hired Dr. Hrishikesh Gadagkar.Based in Pennsylvania, USA, Hrishikesh is a product development and medical device consultant with over 28 years of experience commercializing med-devices.Over 28 years of experience commercializing medical devices for large, mid-size and early stage companies. His expertise spans myriad domains such as product development, medical imaging and regulatory compliance.Upon having multiple conversations and signing the NDA, the freelancer took up the project and analysed the client’s FDA reference documents comprehensively.

  • deadlineProject deadline met
  • ratingstarFreelancer rating:
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Freelance Prod. Development Consultant
PhD, Electrical Engineering
University of Tennessee
Client Says

"I found the freelancer excellent to work with, especially how he took the time to understand our product and the regulations that apply to us . The turn-around time was incredible, and the final conclusions were detailed and backed up with relevant references"