Generate submission-ready Software Requirement Specifications (SRS), Software System Test Cases (SSTC), Software System Test Procedures (SSTP) and Traceability documentation. Manage requirements, formal reviews, and compliance in one purpose-built platform.
Trusted by medical device companies
Logos shown represent organisations whose documentation projects were supported by our consulting team.
Most medical device teams manage their entire software documentation lifecycle in Word, Excel, and shared drives. Here's what that looks like in practice.
Every feature maps to a specific IEC 62304 or FDA requirement. Not a generic doc tool — a purpose-built submission platform.
From first requirement to final release signature — PreQMS handles the entire software documentation lifecycle.
PreQMS combines software with expert-led documentation services. Whether you need a guided setup or a fully managed 510(k) documentation package, our team handles it inside the platform.
We'll review your project and recommend the right service tier. No commitment required.
PreQMS maps directly to the IEC 62304 software lifecycle. No customisation — the process is built in.
Upload your existing Word document and PreQMS extracts requirements automatically. Or start from IEC 62304 templates.
Catch vague, non-testable, or non-conforming requirements before your submission. Each flagged against specific IEC 62304 rules.
PreQMS reads your SRS and generates a draft SSTC test case document. Build your traceability matrix as you go.
Assign qualified reviewers. They approve or comment. Module locked during review. Release creates a baseline automatically.
SRS, SSTC, SSTP, traceability matrix — all formatted for your 510(k) technical file. One click.
Your requirements and documentation are sensitive. Here's exactly how we protect them.
Book a 30-minute demo. We'll walk through the platform and import one of your existing documents together.
No commitment. We'll reach out within 1 business day if you prefer email — sales@preqms.com
We'd been managing our 510(k) SRS in a shared Word document with tracked changes. The reviewer sign-off process alone took two weeks of emailing PDFs. PreQMS cut that to two days — and our FDA reviewer actually complimented the traceability matrix.
Join medical device software teams using PreQMS to write better documentation, pass audits faster, and submit with confidence.
Need expert help? We offer fully managed documentation services — our team does the work inside the platform.