SAL 10⁻⁶ Sterilized
Validated Ethylene Oxide (EO) sterilization cycles conforming to ISO 11135 ensure absolute sterility assurance for surgical suites, emergency rooms, and outpatient clinics.
Founded by Dr. Inam ul Haq Mirza, DR MIRZA Medical Instruments bridges clinical expertise with Sialkot's world-renowned surgical manufacturing heritage. Our single-use surgical instrument program provides sterile, ready-to-use solutions designed to eliminate cross-infection risks, reduce hospital sterilization overhead, and streamline operating room workflows.
Validated Ethylene Oxide (EO) sterilization cycles conforming to ISO 11135 ensure absolute sterility assurance for surgical suites, emergency rooms, and outpatient clinics.
Manufactured under ISO 13485:2016 quality management systems, fully compliant with European Union Medical Device Regulation (EU MDR 2017/745) requirements.
Custom blister pack sealing, procedure-specific kit assembly, customer branding, and private label carton configurations tailored for overseas hospital procurement.
Every product is individually sealed in medical-grade peelable pouches with lot traceability, manufacturing dates, and sterilization indicator strips.
High-carbon steel and stainless steel blades ground to micrometer precision for clean tissue dissection and minimum wound trauma.
Latex-free, non-pyrogenic syringes and precision hypodermic needles crafted from medical polypropylene and AISI 304 stainless tubing.
Precision-molded polymer and stainless steel hybrid forceps engineered for tactile feedback, firm grip, and zero cross-contamination risk.
High-clarity polycarbonate trocars and cannulas for laparoscopic access, thoracic drainage, and vascular cannulation procedures.
Strict quality control protocols guarantee physical performance, mechanical strength, and sterility across all order batches.
| Specification Parameter | Manufacturer Standard | Compliance & Verification |
|---|---|---|
| Raw Materials | AISI 420 / 316L Stainless Steel, Medical Polypropylene (PP), Biocompatible Polycarbonate | ISO 10993 Biocompatibility Certified; Mill Test Certificates available |
| Sterilization Process | Ethylene Oxide (EO) Sterilization conforming to ISO 11135 specifications | SAL 10⁻⁶ verified by biological & chemical indicator strip validation |
| Primary Packaging | Medical-grade paper/film peel-pack blister pouches (ISO 11607 compliant) | Puncture-resistant, moisture-proof with readable lot numbers & expiration dates |
| Quality System | ISO 13485:2016 Medical Device Quality Management Certification | Annual third-party audit verification & complete batch production record (DHR) |
| Regulatory Marks | CE Marking under EU MDR 2017/745; FDA Device Registration support | Full Technical Documentation & Declaration of Conformity provided |
DR MIRZA serves as an established contract manufacturing partner for international medical supply brands, hospital consortiums, and healthcare tenders.
We support tailored production runs matching exact clinical drawings, material requirements, and custom procedure pack assemblies. Our automated packaging lines support high-volume sterile pouch sealing and private labeling.
Direct factory dispatch from Sialkot, Pakistan, combined with structured ocean and air freight logistics guarantees reliable lead times and competitive pricing structures for volume tenders.
Clear technical and commercial answers tailored for hospital buyers, procurement directors, and medical distributors.
Yes. All DR MIRZA single-use instruments are manufactured under strict ISO 13485:2016 Medical Device Quality Management Systems and comply with European CE marking guidelines under EU MDR 2017/745. Technical files, Certificates of Analysis (COA), and Declarations of Conformity are available for regulatory audits.
Our disposable items undergo Ethylene Oxide (EO) sterilization adhering to ISO 11135 specifications, achieving a certified Sterility Assurance Level (SAL) of 10⁻⁶. Every production lot includes chemical indicator strip testing and full aeration validation prior to packaging.
Yes. We offer turnkey OEM services for international healthcare brands and hospital distributors, including custom blister peel-packs, barcode printing, customized procedure kit assembly, and client logo branding on sterile pouches.
We utilize high-tensile medical-grade stainless steel (AISI 420 and 316L) for cutting and clamping ends, alongside biocompatible medical polypropylene and polycarbonate meeting ISO 10993 testing guidelines.