Rubber Components for Medical Devices, Manufactured in India

Margo Rubber Products holds ISO 9001:2015 certification, certificate 09111526A. We are working toward ISO 13485 certification, targeted for 2027. We are not FDA registered. We supply biocompatible silicone components as a moulding capability; regulatory responsibility for the finished device remains with the manufacturer, and we provide the material certificates, batch records and drawing-revision documentation your device file requires.

Biocompatible silicone (VMQ) is the usual choice, −60 to +220 °C and assessed to ISO 10993. Send your biocompatibility standard reference and sterilisation method — autoclave, gamma or ethylene oxide — and we will confirm the compound and what the supplier can evidence.

Clean-room-compatible handling and packaging is available on request. Confirm the class and the bagging requirement with your enquiry so we can quote it — it is a per-order arrangement rather than a standing capability.

Yes — we are a volume manufacturer. Margo produces in bulk against OEM schedules rather than in small lots. Minimum run is 10,000 pieces per part number, per compound, and on larger or more complex parts the minimum is quoted against the part, because the economics are set by tooling and cure time rather than by piece count. Prototype and first-article lots sit outside the minimum and are quoted separately, with a prototype within 48 to 72 hours of an approved drawing.

Yes. Every component is produced against a controlled drawing revision with no substitutions without approval, and the revision is recorded on the despatch documentation. A change to compound, hardness or geometry is quoted and approved as a change, never made silently.