ISO 13485 is now FDA law. Be ready when the investigator arrives.
Since February 2, 2026, 21 CFR 820 builds in ISO 13485:2016. Find your gaps clause by clause, draft FDA-ready procedures, rehearse the inspection and keep your suppliers watched, with a system your own team runs.
A 30-minute call with our team. Our prices are published below.
From scattered SOPs to inspection-ready
- Step 1
Upload what you have
Drop in your existing SOPs and quality manual, a folder or a zip. We read them and map each one to the ISO 13485 clauses it covers.
- Step 2
See every gap, clause by clause
A gap analysis against ISO 13485:2016 as the QMSR incorporates it, with what is missing in each procedure, not just which clause.
- Step 3
Close gaps without a consultant
Draft a missing procedure in minutes, worded for the FDA: Medical Device Reporting (Part 803), corrections and removals (Part 806), complaint records (820.35), labeling (820.45).
- Step 4
Rehearse the inspection
A mock FDA inspection covers the ISO clauses plus what investigators check on top: MDR files, UDI and GUDID, registration and listing, 510(k) records.
And it keeps you ready
Supplier recall watch
Every day we check new FDA recalls and field actions against your supplier register and tell you when one may affect you.
Inspection room for auditors
Give your certification body or a customer's auditor a time-limited, read-only link to your readiness, evidence and supplier register. Every view is logged.
Your team's work, in one list
Each person sees what is theirs: CAPAs, gaps, training, approvals, records due. Reminders arrive before things go late.
A plan with a date on it
Set your inspection or certification audit date and the 90-day plan counts down to it, milestone by milestone.
Pricing in US dollars
Per month, per organization. Pay annually and get two months free. Excludes any applicable sales tax.
Starter
One site getting its QMS in order.
- ✓Up to 5 users
- ✓Document control and records
- ✓ISO 13485 gap analysis
- ✓FDA-worded starter procedures
Growth
Preparing for an FDA inspection or certification audit.
- ✓Up to 20 users
- ✓Everything in Starter
- ✓AI-drafted procedures
- ✓Mock FDA inspection
- ✓Supplier portal and recall watch
- ✓Auditor inspection room
Partner
QA/RA consultants running several clients.
- ✓Up to 10 client organizations
- ✓One login across all clients
- ✓Everything in Growth for each client
- ✓Partner pricing for your clients
| Typical legacy eQMS for a small company | $15,000–$35,000 a year, often with a setup fee |
|---|---|
| Typical consultant-led implementation | $15,000–$75,000, or a monthly retainer |
| ISO 13485 Compliance OS, Growth | $12,500 a year, no setup fee |
Legacy eQMS and consultant figures are published third-party estimates for small companies (2026), not quotes.
Selling in Europe too?
The same QMS is the quality-system half of a CE mark under the EU MDR. Take the free CE readiness check.
CE Mark & Global Markets
Get the CE mark, then keep it, in every market it opens.
- ✓Up to 3 devices, each classified under MDR Annex VIII
- ✓Technical-file checklist with a ready-for-the-notified-body score
- ✓Upload and review of your existing CE / MDR pack
- ✓Draft EU Declaration of Conformity and technical file index
- ✓Every target market's local steps: Switzerland, UK, Turkey, Saudi Arabia, UAE, Australia and more
- ✓PSUR, PMS and vigilance deadlines that keep the CE mark current
CE Pack Review
Already have a CE or MDR pack? Find out where it stands.
- ✓Your existing CE / MDR pack reviewed against the MDR checklist for your device class
- ✓What is covered, what is missing, and what is out of date (MDD, old standards)
- ✓Your ready-for-the-notified-body score and a prioritized fix list
- ✓A 30-minute call to walk through the findings
Excludes applicable taxes. Notified body, authorised representative and testing fees are charged by those parties, not by us. We help you prepare; certification decisions belong to your notified body.
Questions
- What changed with the QMSR?
- Since February 2, 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference and adds FDA-specific requirements, such as complaint and service records, labeling controls, and inspection access to management review and audit reports. FDA inspects against it.
- Is this a substitute for 510(k) clearance or a certification audit?
- No. We help you build and run the quality system and get ready for inspection. Clearance, inspection outcomes and certification decisions belong to the FDA and your certification body.
- We also want to sell in Europe. Can it handle the CE mark?
- Yes. The CE Mark & EU MDR workspace classifies each device under MDR Annex VIII, builds its technical-file checklist, pre-fills the quality-system items from your ISO 13485 work and drafts the EU Declaration of Conformity. One QMS serves the QMSR and the MDR.
- Where is my data?
- In a managed database in the European Union (Ireland), with each organization kept separate by row-level security, multi-factor sign-in and a tamper-evident audit log. The security page has the details.
- How do I pay?
- Book a demo with our team. When you choose a plan, we invoice you in US dollars, monthly or annually.