We are committed to delivering healthcare solutions that meet the highest standards of quality, safety, and regulatory compliance.
As of February 2, 2026, the FDA has officially replaced the old Quality System Regulation(QSR) with the Quality Management System Regulation (QMSR), which aligns directly with ISO 13485:2016.
Since Valphoray sell implants and life-sustaining equipment, Valphoray QMS meticulously integrates risk management must integrate risk management at every stage—from supplier selection to post-market surveillance.
Every piece of equipment, implant, and disposable must have a machine-readable UDI. We are responsible for ensuring these are logged in the GUDID (Global UDI Database) to allow for instant recalls.
For high-risk items (Class III), we must maintain records that trace the item from the manufacturer to the specific patient or hospital department.
Since Valphoray analyze clinical trial data using AI, we are subject to the FDA’s "Risk-Based Credibility Assessment" and the EMA’s Annex 22 (which became effective in late 2025).
Data analysis is always Attributable, Legible, Contemporaneous, Original, and Accurate. In 2026, the "+" includes Traceability— Valphoray seamlessly replays an AI analysis to show how a specific conclusion was reached.
An AI. We must have a Computer System Validation (CSV)package that proves the model is "Fit for Purpose."
Clinical trial results cannot be signed off by an AI. A qualified human must review and endorse every "AI-generated" summary or data flag.
Blood bank equipment carries some of the highest regulatory burdens due to the risk of contamination and life-critical nature.
For disposables and blood bags, we include Batch Release Testing and validation of the "Cold Chain" (ensuring equipment maintains temperature integrity during transit).
In many regions (like India under CDSCO or the US under FDA), selling blood bank equipment requires specific Form 28 type licenses. Valphoray must document the "Hygienic Conditions" of Valphoray storage facilities.
For any disposables that touch blood, Valphoray must maintain ISO 10993 records proving the materials don't leach toxins into the blood supply.
This policy fulfills the requirements of ISO 13485:2016 (Medical Devices), ICH-GCP (Clinical Trials), and FDA 21 CFR Part 11 (Electronic Records).
| Activity | Primary Regulation | Key Compliance Artifact |
|---|---|---|
| Data Analysis (AI) | GCLP / FDA 21 CFR Part11 | AI Validation Protocol & Audit Trails |
| Implant Sales | QMSR / ISO 13485 | Traceability Logs & UDI Registration |
| CRO Activities | GCP (Good Clinical Practice) | Site Monitoring Reports & Ethics Approvals |
| Blood Bank Equip. | Blood Safety Mandates | Sterility & Calibration Certificates |
| Disposables | ISO 11135 (Sterilization) | Biocompatibility (ISO 10993) Reports |
To manage this many moving parts, we use an AI-powered eQMS (electronic Quality Management System).
We use AI to "self-audit" clinical data logs against SOPs (Standard Operating Procedures) in real-time.
Instead of waiting for a failure, use Valphoray AI to predict which medical equipment batches might be prone to failure based on supplier data trends.
