Built around the evidence regulators ask for.
Post-market quality work is defined by a few standards and regulations. MDARIX organizes the evidence they call for. It does not certify compliance: your quality system and its validation stay yours.
FDA, EU MDR, UK and Canada reporting.
Each window is counted from the day you became aware, and each reportability decision keeps its reason. People decide what is reportable; MDARIX never submits anything to a regulator.
- 21 CFR 803.50 30-day reports by manufacturers
- 21 CFR 803.53 5-day reports
- EU MDR Art. 87 Reporting of serious incidents and field safety corrective actions
- UK MDR 2002 (as amended) Post-market surveillance and vigilance (Great Britain)
- SOR/98-282 ss. 59–61 Mandatory problem reporting (Canada)
MDARIX organizes the evidence these ask for; it does not certify compliance. Your quality system and its validation stay yours.
The standards behind post-market quality work.
What each one asks for, and how MDARIX helps you show it.
Medical devices: quality management systems
- What it asks
- Complaint handling (8.2.2), corrective and preventive action (8.5.2, 8.5.3) and controlled records.
- How MDARIX helps
- Every complaint is linked to its product version, lot, component and supplier, with the investigation and CAPA beside it.
FDA 21 CFR 820, in force since 2 February 2026
- What it asks
- ISO 13485 by reference: complaint files, failure investigations and CAPA records the FDA can inspect.
- How MDARIX helps
- One investigation record holds the question, the evidence, the competing explanations and the signed decision.
Application of risk management to medical devices
- What it asks
- Production and post-production information must flow back into the risk file.
- How MDARIX helps
- Complaints and failure modes are linked to the risks and controls they touch, so field signals reach the risk file.
Medical device software life cycle
- What it asks
- A problem resolution process for software, with traceability to versions and changes.
- How MDARIX helps
- Firmware versions are part of each product version, and engineering changes are linked to the complaints that follow.
FDA 21 CFR 11: electronic records and signatures
- What it asks
- Trustworthy electronic records, signatures with meaning and an audit trail that cannot be altered.
- How MDARIX helps
- Signatures need re-authentication and record their meaning and a content fingerprint; the audit trail is append-only.
FDA 21 CFR 803: medical device reporting
- What it asks
- Timely reports of deaths, serious injuries and malfunctions, from the date of awareness.
- How MDARIX helps
- Awareness date, serious injury, death and malfunction flags travel from the complaint system for reportability review.
Regulation (EU) 2017/745, Articles 83–92
- What it asks
- Post-market surveillance, vigilance and trend reporting of statistically significant increases (Article 88).
- How MDARIX helps
- Trends by version and lot show when and where complaints change, with the records behind every point.
Adverse event terminology
- What it asks
- Consistent problem codes so events can be grouped and compared.
- How MDARIX helps
- Problem codes are carried from the source system and grouped across products and sites.
MDARIX is not yet a validated (GxP) system and does not hold ISO 27001 or SOC 2 certification. It never submits anything to a regulator.
Security at MDARIXReportability decisions are recorded by a named person with their reason. Investigation decisions are signed electronically, with re-authentication.
Trust on the PlatformBring one real investigation. See the whole story in one place.
Start with exports from your quality, product and supplier systems. Your systems of record stay where they are.