Client 1

QMS Architecture for AI Diagnostics Startup

CHallenge:

_{Early-stage AI diagnostics startup preparing for FDA pre-submission required a compliant, investor-ready QMS framework.}

Approach:

_{Built a modular QMS aligned to ISO 13485:2016, integrating document control, design control, and CAPA workflows using scalable SOP tiers.}

Outcome:

_{Achieved internal audit readiness within eight weeks, enabling smoother investor compliance verification and accelerating pre-market submission readiness.}

Project Status:

Ongoing

Client 2

N/A

CHallenge:

_N/A

Approach:

_N/A

Outcome:

_N/A

Project Status:

Onboard