SequenceQMS: the eQMS built for medical device companies
SequenceQMS runs document control, design controls, risk, CAPA, change orders and training in one place. It is built for 21 CFR Part 11 and aligned to ISO 13485 and FDA's QMSR, so your team stays audit-ready.
| Document | Version | Status | Owner |
|---|---|---|---|
| SOP-001: Design Control Process | 3.0 | Approved | S. Chen |
| SOP-012: CAPA Management | 2.1 | Approved | J. Park |
| WI-045: Risk Assessment | 1.2 | Review | M. Santos |
| QF-110: Complaint Form | 4.0 | Approved | R. Patel |
| TMP-003: DHF Template | 1.0 | Draft | K. Lee |
Everything You Need to Manage Quality
One platform for every quality process, from design to post-market.
Document Control
Manage the complete document lifecycle with automated routing, version control, and electronic signatures built for 21 CFR Part 11.
Design controls and the design and development file
Full traceability from user needs through verification and validation. Auto-generate your design and development file with one click.
Risk Management
ISO 14971 aligned risk analysis with FMEA worksheets, 5×5 risk matrix heatmaps, and automated risk scoring.
CAPA & Quality Events
7-stage CAPA workflow, nonconformance tracking, customer feedback intake, and audit management, all connected.
Change Orders
Formal change control with impact assessment, document linking, and approval routing for regulated changes.
Training Management
Auto-assign training when documents change. Track completion, manage curricula, and maintain audit-ready training records.
Why SequenceQMS?
Built differently. Built better. Built for medical devices.
Purpose-Built for MedTech
Not a generic QMS. Every feature designed for FDA, ISO 13485, and medical device workflows.
Weeks, Not Months
Go from signup to audit-ready in weeks with guided implementation and pre-built templates.
AI-Powered Quality
AI drafts documents and checks for gaps. People review, approve and sign.
Affordable & Scalable
Enterprise features at startup-friendly pricing. Grow from first device to full portfolio.
Frequently asked questions
- What is SequenceQMS and who is it for?
- SequenceQMS is a cloud electronic quality management system (eQMS) for medical device companies, from a first device to a full portfolio. It runs document control, design controls, risk management, CAPA, change orders and training in one place. Sequence Group, a medical device quality and regulatory consultancy, builds and operates it.
- Does SequenceQMS support 21 CFR Part 11 electronic signatures?
- Yes. SequenceQMS is built for 21 CFR Part 11, with electronic signatures and a full audit trail of who changed each record and when. Signing always stays with a person: the AI assistant drafts and checks, but it never signs.
- How does SequenceQMS relate to the QMSR and ISO 13485?
- SequenceQMS is aligned to ISO 13485:2016 and to FDA's Quality Management System Regulation (21 CFR Part 820), which incorporates ISO 13485 by reference. It gives your team the controls for the records both require. Your quality system, and any certificate it earns, remain your company's own.
- What does the free trial include?
- The free trial gives your team a SequenceQMS workspace for 14 days. Every trial request is reviewed by our team before the workspace opens, and a payment card is required once the trial is approved.
- How much does SequenceQMS cost?
- SequenceQMS is priced per user for each module, with lower rates at 25 and 100 seats. When prices are published they appear in the Pricing section of this page; otherwise, request a demo and we will send a quote.
Ready to modernize your quality system?
See how SequenceQMS can help your team keep its quality records in order, cut audit prep time and bring safer devices to market faster.
Start your free trialOr ask for a guided walkthrough: