PEKS

PEKS Platform

Explore PEKS Platform and its approach to structured engineering knowledge, risk relationship modeling, control and verification mapping, and AI-assisted engineering documentation.

Platform positioning

PEKS Platform is the product and technical implementation under the PEKS brand, focused on engineering knowledge, evidence relationships, and engineering workflows. It is not general-purpose AI infrastructure and not a mature commercial SaaS product.

Current capabilities

The following capabilities must be verified against the actual implementation before publication:

  • Structured engineering knowledge and evidence organization (Demonstrable, subject to walkthrough confirmation)
  • Hazard–mechanism–harm–control–verification relationship modeling (Demonstrable, subject to walkthrough confirmation)
  • AI-assisted engineering document generation (Demonstrable; public samples show the first two chapters)
  • Multi-device knowledge organization: balloon / stent / guidewire (Demonstrable, subject to walkthrough confirmation)
  • CER review workflow (Under Development); PEKS CER Intelligence as a standalone product direction (Planned)
  • Usability / UEF workflow (Under Development); PEKS Usability as a standalone product direction (Planned)
  • Verification mapping integrated in RMF (Demonstrable); PEKS Verification Planner as a standalone product direction (Planned)

Workflow

Evidence collection → evidence normalization → knowledge structuring → risk relationship modeling → control and verification mapping → document generation → human review.

The workflow supports structured organization and traceability. It does not replace qualified risk management decisions or formal approval.

Capability status

Every capability statement on this page must be checked against the actual implementation. Items marked Planned or Conceptual Research are not existing features.

Further reading

The Demonstrations page describes currently observable workflows and outputs. The Technology page explains knowledge modeling, evidence processing, and the human-review boundary.

Discuss an engineering problem

To discuss medical device R&D, risk management, engineering documentation, or AI-assisted workflows, contact PEKS by email.

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