Knowledge-driven engineering and AI-assisted workflows

The engineering problem

Engineering knowledge is often scattered across documents, spreadsheets, and disconnected systems. The relationships between design inputs, risks, controls, and verification evidence are usually maintained manually.

• Engineering knowledge is fragmented and hard to reuse
• Relationships between design, risk, controls, and verification evidence are weak
• Engineering and regulatory documentation involves repetitive manual work
• Maintaining consistency after design or process changes is costly
• Traceability between engineering decisions and supporting evidence is limited

The PEKS approach

PEKS starts from engineering evidence, organizes it into structured knowledge, and connects risks, controls, and verification activities through explicit relationships. AI supports organization, analysis, and documentation workflows; engineering judgment and approval remain with qualified people.

• Evidence collection and normalization
• Engineering entity and relationship modeling
• Control and verification mapping
• AI-assisted workflows
• Human review and accountability boundaries

PEKS Platform

PEKS Platform is the product and technical implementation under the PEKS brand. Its current focus is the risk management engineering workflow (PEKS RMF Core). Every capability is labeled Demonstrable, Under Development, Planned, or Conceptual Research; planned capabilities are not presented as existing features.

FDE & Expertise

FDE & Expertise presents the genuine engineering experience, manufacturing and validation practice, and industry FDE implementation methodology behind PEKS. Individual employment experience and independent PEKS development are attributed separately.

Collaboration

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