Quality Management Systems & International Certifications
Audited and certified by recognized Notified Bodies for seamless European customs clearance and hospital procurement.
ISO & CE Regulatory Portfolio
Medical Devices — Quality Management Systems
Demonstrates complete compliance with regulatory requirements for medical device quality management from raw material receiving to finished product delivery.
Design, Development, Manufacturing, and Distribution of Nonwoven Medical Textiles, Surgical Gowns, PPE Coveralls, and Disposable Medical Accessories.
Quality Management System Certification
Guarantees continuous process optimization, standardized testing procedures, customer satisfaction, and rigorous supplier quality audits.
Quality Management Systems governing industrial nonwoven fabric extrusion, spunmelt processing, conversion, and global export operations.
EU Medical Device Regulation Compliance
Verifies technical documentation, clinical evaluations, risk management under ISO 14971, and EU Declaration of Conformity for European Union imports.
Class I & Class I Sterile Medical Devices including Surgical Gowns, Surgical Drapes, and Bed Cover Accessories.
EU Personal Protective Equipment Regulation
Ensures essential health and safety compliance for protective garments exported into the European Economic Area.
Category III Complex Risk Protective Clothing (Type 3-B, Type 4-B, Type 5-B, Type 6-B Coveralls and FFP2/FFP3 Respirators).
Harmonized European Test Protocol Verification
Every production batch processed in our Multan cleanrooms undergoes standardized lab testing. Certificate of Analysis (CoA) and test reports are attached to every commercial export invoice.
Tests fluid resistance, hydrostatic pressure, linting, microbial cleanliness, and dry/wet tensile burst strength.
Protective clothing against infective agents, synthetic blood penetration, and viral penetration (ISO 16604).
Bacterial Filtration Efficiency (BFE ≥ 99.8%), differential pressure (Delta P), and splash resistance pressure (16 kPa).
Request Quality Dossier
For EU customs compliance & hospital tenders
European procurement managers can request full Notified Body audit reports, Declaration of Conformity (DoC), technical construction files (TCF), and EC REP contact details directly.