Our Services

Safety Analyses

Do you have a safety plan? Do you have a risk management plan? Do you need to perform fault tree analyses, functional hazard assessments, or specific risk assessments for critical functionality?

  • In aviation, you’ll generally want to reference SAE ARP 4754A for System Development and SAE ARP 4761 for System Safety Assessment.

  • For medical devices you’re looking for ISO 14971 for risk management, IEC 62304 for medical device software lifecycle management, and ISO 13485 and 21 CFR 820.30 for Quality Management Systems that are adherent to FDA guidance.

Reliability (Functional Testing)

What is your plan for verifying your system? Are your product requirements able to be tested? Are you using automation where you should be? Do you know how to compute your forward looking MTBF per MIL-HDBK-217F?

The best way to guarantee that you make a reliable product is to set S.M.A.R.T. objective criteria for your design target within your requirements, and vigorously test against them.

Regulatory Compliance

At Purposeful Function, we offer comprehensive Regulatory Compliance Services to guide organizations in meeting essential industry standards and requirements. Our services encompass a diverse range of regulatory needs, including medical device requirements tracing to standards, authoring of functional avionics requirements for civil, commercial, and defense applications, and development of quality and project management procedures and processes.

Project Management

Patrick, founder of Purposeful Function, has an impressive track record of managing $2.5 million of annual revenue for contracted medical device development and production. He excels at project scheduling through both retrospective and interview resource estimation techniques. Often, agile-like development methods are appropriate, and he thrives in the roll of scrum master, keeping the pulse of development beating.

Patrick's expertise extends to project lifecycle financial forecasting, ensuring we stay on budget throughout an entire development effort. The results-driven approach focuses on efficiency and successful project outcomes, making sure we deliver exceptional results for our clients' ventures.