Since February 2026 the FDA's Quality Management System Regulation incorporates ISO 13485. Keep risk files, complaints, CAPA, nonconformances, documents, training, calibration and suppliers in one workspace, with controlled records and signatures.
People who only need to look, such as managers, auditors and customers, get free viewer seats.
Screens show sample data from a fictional company.
Qualsted gives you the technical controls and the records; your procedures, training and verification of your own configuration complete the picture.
| Clause | How Qualsted helps |
|---|---|
| ISO 13485 §4.2.4, §4.2.5 | Control of documents and records. Documents reviewed and approved before use, versions kept, records protected, retrievable and never deleted. |
| ISO 13485 §7.1 · ISO 14971 | Risk management. A risk register per product with severity, probability, risk controls and residual risk, reviewed and approved. |
| ISO 13485 §8.2.2 | Complaint handling. Complaints from receipt to closure with investigation, reportability decision and approval. |
| ISO 13485 §8.3 | Nonconforming product. Identification, disposition and approval of nonconforming product, linked to CAPA. |
| ISO 13485 §8.5.2, §8.5.3 | Corrective and preventive action. CAPA with root cause, actions, effectiveness check and approval, with reminders before due dates. |
| 21 CFR Part 11 | Electronic records and signatures. Signatures with meaning and re-authentication, linked to content; an append-only audit trail. |
Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.
A risk register per product: hazards, hazardous situations and harms, severity and probability before and after risk controls, verification of the controls, and Quality's approval, with a yearly review.
ISO 14971:2019 · ISO 13485 §7.1 · FDA QMSR (21 CFR 820) · EU MDR Annex I
Customer complaints from receipt to closure: investigation, reportability decision, response, and QA approval.
21 CFR 211.198 · FDA QMSR (21 CFR 820) · ISO 13485 §8.2.2 · ISO 9001 §9.1.2
Record deviations, assess their impact, and open a corrective and preventive action when one is needed. CAPAs are reviewed and approved, with reminders before they fall due.
21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1
Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.
ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7
Controlled documents with versions, review and approval. Each document gets a periodic review date two years ahead, and its owner is reminded a month before it's due.
21 CFR 211.100 · FDA QMSR (21 CFR 820) · ISO 9001 §7.5 · ISO 13485 §4.2.4 · ISO/IEC 17025 §8.3
Approved suppliers with their risk, certificates and qualification, approved by Quality and requalified every year.
FDA QMSR (21 CFR 820) · ISO 9001 §8.4 · ISO 13485 §7.4 · AS9100 §8.4 · EU GMP Ch. 5
The assistant answers questions about your tables, draws charts and summarizes long records. It sees only what you can see, never changes or signs anything, and every use is logged.
Which risks for product X still have a residual risk of High?
Summarize complaint CMP-0042 and its investigation.
Answers come from the records you can see, with charts and links to them.
You can build design inputs, outputs, verification and reviews as linked tables with signatures. There's no ready-made design-control template yet; the risk management template covers ISO 14971.
Every release comes with a validation report (requirements traced to automated tests). You verify your own configuration for its intended use, as ISO 13485 §4.1.6 asks.
