Every Hr-Surgicals instrument is backed by internationally recognised quality certifications. Our compliance programme is not a formality — it's the foundation of every instrument we make.
ISO 13485 is the gold standard for medical device quality management systems. It mandates rigorous process control, risk management, traceability, and continuous improvement across every stage of our manufacturing — from raw material receipt to finished goods dispatch.
CE marking confirms that our products comply with the EU Medical Device Regulation (MDR 2017/745). This covers essential safety and performance requirements, clinical evaluation, post-market surveillance, and technical documentation reviewed by an EU Notified Body.
WHO prequalification confirms that our sterilization products and procedure kits meet international standards for safety, quality, and performance — a critical requirement for supply to UN agencies, NGOs, and government health ministries in over 100 countries.
Our quality management system is built on ISO 13485 principles and applies to every stage from raw material to delivery. No instrument ships without passing through every gate.
All incoming steel is tested for grade, hardness, and composition against our approved supplier qualification records.
Dimensional checks at each machining stage. Every operator follows signed-off work instructions traceable to the batch record.
100% visual inspection and functional testing. Instruments failing any criterion are quarantined and disposition-reviewed.
Representative samples undergo cytotoxicity, sensitisation, and irritation testing per ISO 10993 for new and modified products.
EO sterilization with validated cycle parameters. SAL 10⁻⁶ maintained. Every sterile batch includes biological indicator records.
No batch ships without a completed DHR. Full traceability from raw material heat number to final customer delivery.
Certificates of conformity, material safety data sheets, biocompatibility reports, and batch-specific DHRs are available on request for all products.