PreQMS analyzes your design controls, software lifecycle documentation, risk management files, cybersecurity evidence, and verification records to tell you exactly how close you are to submission readiness.
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.
PreQMS reads your design controls, software lifecycle, risk, cybersecurity and verification records — and turns them into a score, a gap list, and a plan.
All measured on top of the full platform: requirements (SRS), test cases & procedures (SSTC/SSTP), the traceability matrix, fault tree analysis, risk management, formal review & sign-off, and baselines & version control.
Self-serve plans for medical-device teams. Every paid seat is billed per unit — no bundles, no minimums — and you can add AI credit packages to any paid plan.
Run multiple client workspaces from one account, with credits pooled at the top. $149 per consultant seat & $99 per client workspace, billed monthly. Up to 5 seats + 5 workspaces self-serve.
Credits power AI requirement review, generation and assisted imports. Delivered each month — pick the tier that matches your volume.
1 credit ≈ 25 requirements · delivered monthly, no rollover · cancel anytime. Free and Business plans include one-time starter credits to try AI first.
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.