A VC-funded healthcare startup needed to validate the security of its innovative wearable medical device and cloud platform for FDA approval.
Through detailed security assessment and documentation, Chaleit helped the company transform regulatory requirements into practical security assurance.
The challenge
The organisation faced complex compliance requirements involving both cloud infrastructure and medical device security, with FDA approval demanding exceptionally detailed security validation.
Key issues included:
Hybrid security architecture spanning device and cloud
Complex FDA documentation requirements
Strict regulatory compliance needs
Time pressure from VC funding
Need for specialised security validation
"FDA compliance required not just testing, but comprehensive documentation of every security aspect — from methodology to specific technical controls," noted Chaleit’s VP of Technical Services.
The solution
Chaleit implemented a thorough approach focusing on both security validation and compliance documentation.
Security assessment
Evaluated cloud-based analytics platform
Assessed mobile application security
Validated communication protocols
Tested security architecture
Simulated device interactions
Compliance documentation
Created detailed methodology documentation
Developed comprehensive security reports
Provided specific compliance evidence
Iterated documentation for requirements
Supported approval process
The outcome and aftermath
The engagement yielded significant deliverables for the start-up.
Security validation
Comprehensive application security testing
Detailed security architecture review
Communication protocol validation
Cloud platform security assessment
Mobile application security verification
Documentation excellence
FDA-compliant security reports
Detailed testing methodology
Comprehensive control documentation
Multiple report iterations
Regulatory submission support
The Chaleit team’s healthcare security expertise helped the company meet strict regulatory requirements while supporting urgent timeline needs, making this a successful engagement. This involved being prepared to support our client with many iterations until a workable and compliant output was achieved in a very specific use case.
Key takeaways
Medical device security requires specialised expertise.
Documentation quality matters as much as security testing.
Regulatory compliance needs adaptable security partners.
Startup timelines demand flexible security approaches.
Healthcare innovation goes hand in hand with security innovation.
This engagement demonstrates how organisations can transform regulatory security requirements into practical compliance achievements. Through detailed documentation and thorough security validation, the client progressed toward their FDA approval goals.
