Assurance

Quality & compliance

Certificates and registration evidence are issued for specific scopes and product lines. Exact validity, annexes, and applicable SKUs are confirmed during vendor qualification — not inferred from this page alone.

Graphics below are illustrative only and are not offered for verification. Current certificate numbers, validity, annexes, and scopes are released to qualified buyers on request.

Certifications & assurance

ISO management system certificates and OEKO-TEX® textile assurance are summarized here; scopes and certificate data are confirmed on request.

  • Illustrative graphic: ISO 9001:2015 (not for verification)

    ISO 9001:2015

    Certified quality management system — design and production of selected cotton-based medical devices and textiles, per certificate scope.

  • Illustrative graphic: ISO 13485:2016 (not for verification)

    ISO 13485:2016

    Certified medical devices QMS for defined product families; audit cycles maintained with the issuing body as applicable.

  • Illustrative graphic: ISO 14001:2015 (not for verification)

    ISO 14001:2015

    Certified environmental management — waste segregation, effluent controls where relevant, and resource use monitoring, per certificate scope.

  • Illustrative graphic: ISO 45001:2018 (not for verification)

    ISO 45001:2018

    Certified occupational health and safety for manufacturing and warehouse operations, per certificate scope.

  • Illustrative graphic: OEKO-TEX certification mark (not for verification)

    OEKO-TEX® · textile & chemical assurance

    Programs such as STANDARD 100 are issued by ICTS for applicable articles in scope — certificate numbers and product classes are listed in the technical data pack for each line.

    Restricted substance management aligns with customer markets; full RSL declarations are shared under confidentiality for tender and hospital onboarding.

Pakistan DRAP

Medical device registration with the Drug Regulatory Authority of Pakistan is maintained for qualifying products. Reference ELM-0112 appears on documentation where that registration pathway applies. Importers and distributors should verify current registration status against DRAP public notices and our release documentation at time of shipment.

This website does not constitute regulatory advice or a substitute for approved labelling and IFU.

Request current certificate references and numbers for vendor qualification through Contact / Enquiry.