Small engineering teams shouldn’t have to slow down their agile hardware sprints to please traditional paper-heavy QMS systems. PMX OS automatically synthesizes an audit-grade Design History File (DHF) directly from your engineering repository commits, CAD models, and bench test logs.
In an early-stage medical device startup, every dollar and every week counts toward milestone survival: proof of concept, pre-sub meeting with FDA CDRH, or Series A financing.
Traditional MedTech quality systems demand that you freeze design specifications before you even know if the circuit will function. Founders either hire high-priced regulatory consultants who spend 70% of their billing hours chasing documentation, or they build fast in complete "compliance debt"—only to face a paralyzing 6-month pause to reconstruct their DHF from scratch before filing.
Most Series Seed and Series A startups retain 1 to 2 specialized regulatory and quality consultants at $350–$600/hr. In traditional environments:
PMX OS integrates invisibly into your engineering flow, transforming your code and CAD commits into structured regulatory assets.
Commit firmware or push SolidWorks revisions as usual. PMX OS extracts BOM metadata and binds commits directly to system requirements (REQ), eliminating manual change orders.
Generate FDA 21 CFR 820.30 and ISO 13485:2016 compliant Design History Files on demand. Every revision is backed by cryptographic timestamps and verifiable test hashes.
Provide external consultants with role-based access to the living knowledge graph. They review and sign off on risk mitigations without leaving their browser.
How a 12-person biomedical engineering team navigated critical hardware changes under severe timeline pressure.
With 14 weeks remaining before their planned FDA Q-Submission, the supplier for the primary skin contact temperature transducer (S-18) informed the team of an 18-month lead time.
The hardware lead immediately sourced an alternative transducer, S-22. In a conventional startup, the engineer would solder S-22 onto the PCB, update the local Git repo, and mention it casually on a Monday standup.
Because the startup ran PMX OS, committing the new Altium schematic triggered an immediate graph evaluation.
PMX OS alerted the engineering lead and their external RA advisor that transducer S-22 altered the thermal dissipation profile against REQ-0184 (skin surface temperature ≤ 41.0°C per IEC 60601-1-11) and intersected biological hazard RSK-0044.
The team executed bench protocol V-0183 that afternoon, uploaded the thermal chamber data logger CSV into PMX OS, and cryptographically verified compliance. The external consultant approved the delta within 20 minutes.
A structured regulatory maturity model that expands as your team and valuation grow.
Capture user needs and initial hazard analyses without slowing down bench experimentation. Connect GitHub and CAD repositories to establish preliminary traceability.
Lock design inputs, conduct formal Design Verification (DV), and generate pre-submission packages for FDA 510(k), De Novo, or CE mark technical documentation.
Link post-market complaints (MAUDE) and CAPA records directly back to the design graph. Maintain continuous change control as contract manufacturers scale production.
Stop dreading compliance. Experience how PMX OS turns design history into an agile engineering superpower.