Standards & Quality Requirements for Fiberglass Cast Bandages

Bringing a fiberglass cast bandage to market requires a robust quality system and clear technical evidence to ensure patient safety, clinical performance, and regulatory compliance—especially for export to the EU. This overview maps the core ISO frameworks and CE requirements from QMS and risk management to labeling, performance evidence, and post-market surveillance.

Quality documentation desk with technical file folders, audit checklists, and labeling compliance for a medical device

1) Quality Management System

ISO 13485: foundation for medical-device QMS—document control, design & development, purchasing, production, traceability, nonconformity handling, and CAPA.
Supplier control: qualification and ongoing monitoring of fiberglass fabric, water-activated resin, and packaging specs; incoming inspection.
Process monitoring: resin impregnation uniformity, weight consistency, humidity/temperature controls, and batch records retention.

Laboratory layout for mechanical testing of fiberglass casting tape including tensile and flexural fixtures

2) Performance & Safety Evidence

Mechanical tests: tensile/modulus, flexural stiffness/strength, creep/fatigue, interlaminar bonding—clear acceptance criteria and repeatability.
Clinical suitability: molding/contouring, gel/cure time, layer integrity, stability in daily loads.
Stability & storage: shelf-life validation at recommended conditions (temperature/humidity), end-of-life performance checks.

3) Risk Management & Biocompatibility

ISO 14971: identify hazards (pressure rings, skin irritation, moisture ingress, use errors), evaluate/control risk, document benefit–risk.
Biocompatibility: per ISO 10993 (selected endpoints for superficial/prolonged skin contact), e.g., cytotoxicity, sensitization, irritation as applicable.
Usability: use-error analysis and clear IFU for activation, wrapping, and care (aligned with IEC 62366-1 principles).

4) Product Information & Labeling

ISO 15223-1: standardized symbols (lot, expiry, storage, non-sterile, etc.).
ISO 20417: IFU requirements: directions for use, warnings, storage (e.g., 15–30°C and RH < 60%), precautions, disposal.
UDI & traceability: EU MDR-compliant UDI for field traceability and potential recalls.

5) CE Marking in the EU

MDR (EU) 2017/745: device classification (often Class I for non-sterile, non-measuring tapes; reassess if special features/claims apply).
Technical File: device description/specs, risk management, clinical evaluation/evidence, testing, and PMS/PMCF plans.
Declaration of Conformity & CE mark: after demonstrating conformity with General Safety & Performance Requirements.

6) Change Control, Complaints & PMS

Change control: assess impact of material/process/supplier changes on safety and performance.
Complaints & CAPA: root-cause analysis, corrective/preventive actions, feedback into design/production.
Post-market surveillance: collect field data, trend analysis, and updates to the risk file/tech file.

Fiberglass cast bandage packaging with standardized ISO symbols and UDI for regulatory compliant labeling

Conclusion & CTA

ISO/CE alignment is not just a regulatory checkbox—it’s a framework for consistent quality and market trust. Explore our export-ready fiberglass casting tapes on the product page.