Comprehensive Quality Management System Across Every Production Phase
At Sterimed Group, Quality Assurance is embedded into every stage of our manufacturing lifecycle. From raw material resin validation and precision extrusion to cleanroom assembly, automated pouch sealing, and terminal Ethylene Oxide (EO) sterilisation, our protocols ensure uncompromising clinical safety and physical integrity.
Our state-of-the-art manufacturing complexes operate under rigorous internationally audited guidelines. This allows overseas medical device distributors, hospital groups, and tender procurement authorities to streamline regulatory submissions with full dossier transparency.
- 100% incoming raw material inspection for medical-grade biocompatibility and purity.
- In-line dimensional, tensile, and balloon burst pressure testing for urology & airway devices.
- Validated terminal EO sterilisation cycles complying with ISO 11135 standards.
- Full lot traceability with archived retain samples for complete post-market audit readiness.
Controlled Cleanroom Environments & Bio-Burden Controls
To ensure minimal microbial load and particulate counts before terminal sterilisation, Sterimed maintains advanced cleanrooms equipped with continuous environmental monitoring.
HEPA Air Filtration
Industrial Air Handling Units (AHUs) fitted with HEPA filters maintain positive differential pressure, controlling micro-particles across assembly and packaging zones.
Antibacterial Epoxy Coating
Seamless epoxy-coated walls and flooring eliminate micro-crevices, facilitating daily sterile washdowns and preventing microbial retention.
Automated Touch-Free Lines
Precision liquid silicone dipping, extrusion, and pouch sealing equipment minimise direct human contact to preserve product integrity.
Global Certification Support for Overseas Importers & Tender Committees
International market entry requires complete, auditable regulatory evidence. Sterimed provides distributors with complete technical files, Certificate of Free Sale (CFS), certificates of analysis (CoA), and biocompatibility reports per ISO 10993 requirements.
Our dedicated R&D laboratory and regulatory affairs team continuously refine device design while helping global partners navigate registration protocols across Europe, Latin America, Africa, the Middle East, and Asia-Pacific.
ISO 13485:2016
Device-specific Quality Management System covering product design, risk control, and post-market surveillance.
CE Marking Compliance
Comprehensive technical dossiers aligned with European Medical Device Directives and MDR requirements.
WHO-GMP Standards
Good Manufacturing Practice compliance ensuring verified equipment calibration and environmental safety.
ISO 11135 EO Sterilisation
Ethylene Oxide sterilisation cycles with routine biological indicator testing and residual gas analysis.
ISO 10993 Biocompatibility
Extensive testing data for cytotoxicity, sensitisation, and systemic toxicity for patient safety.
100% Lot Traceability
Unique batch numbering printed on primary pouches and export cartons for instant track-and-trace auditability.
Request Technical Dossiers or Audit Our Production Facilities
Partner with an established medical device manufacturer with over 65 years of export experience and certified quality management.