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Our Certificates
Our quality standards, management systems and exemplary regulatory compliance, all contribute to the global success of the company. Our capabilities have been assessed and certified by the following international governing bodies.
ISO 9001 : 2015
ISO 13485 : 2016
Brightway (Plant 1), Laglove, Biopro
Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves
Directive 93/42/EEC on Medical Devices, Annex V
Brightway (Plant 1), Laglove, Biopro
Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves
NextTech Certificate of Compliance
Brightway
ISO14644 compliance
Medical Device Act2012 (ACT 737) Establishment Licence
Brightway, Laglove, Biopro
Manufacturer
MDSAP (US, Canada, Japan, Australia, Brazil)
Certified 510K Premarket Approval (FDA)
PPE Module D (CE)
SEI NFPA (Registered Facility)
Member of SMETA
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