Every Suture Planet device is manufactured under an ISO 13485 quality system, USP-compliant and biocompatibility tested. The certificates below are current and available on request for your registration.
Quality management system for medical devices — the backbone of our design, production and traceability controls.
Conformity under EU Regulation 2017/745 with maintained technical documentation per device family.
Good Manufacturing Practice certification for the Bengaluru manufacturing site.
General quality management certification covering the wider organisation and processes.
Government-issued certificate confirming products are freely sold in the country of origin — for export registration.
Confirms the manufacturer's standing and manufacturing licence status for regulatory submissions.
Medical-grade polymers and needles verified against specification and certificate of analysis before release.
Diameter, tensile, knot-pull and needle-attachment tested to USP/EP limits throughout production.
Products evaluated for biocompatibility and sterility assurance per applicable ISO 10993 standards.
ETO sterilisation validated; every finished box traceable to raw polymer lot and process records.
We share ISO, CE, WHO-GMP and free-sale documents with qualified distributors and regulatory bodies.
Request documents