Quality that you can trust — and verify.
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.
Certifications on file
Current certificates, available on request for your product registration and audits.
ISO 13485:2016
Quality management system for medical devices — the backbone of our design, production and traceability controls.
CE / EU MDR
Conformity under EU Regulation 2017/745 with maintained technical documentation per device family.
WHO-GMP
Good Manufacturing Practice certification for the Bengaluru manufacturing site.
ISO 9001:2015
General quality management certification covering the wider organisation and processes.
Free Sale Certificate
Government-issued certificate confirming products are freely sold in the country of origin — for export registration.
Market Standing Certificate
Confirms the manufacturer's standing and manufacturing licence status for regulatory submissions.
Controls at every stage.
Incoming materials
Medical-grade polymers and needles verified against specification and certificate of analysis before release.
In-process checks
Diameter, tensile, knot-pull and needle-attachment tested to USP/EP limits throughout production.
Biocompatibility
Products evaluated for biocompatibility and sterility assurance per applicable ISO 10993 standards.
Batch traceability
ETO sterilisation validated; every finished box traceable to raw polymer lot and process records.
Need our certificates for registration?
We share ISO, CE, WHO-GMP and free-sale documents with qualified distributors and regulatory bodies.
Request documents