Quality Assurance & Certification
The Quality Control Laboratory at SurgiKart India has obtained certification for conducting biological, chemical, microbiological, physical, sterility, and toxicity tests. Equipped with state-of-the-art technology, the laboratory is staffed with qualified and trained personnel.
SurgiKart India’s Quality Control System encompasses a systematic and fully documented approach, conducting comprehensive and exhaustive bacteriological, chemical, physical, and visual tests. The system ensures inspections at every relevant stage of the production cycle, including constant surveillance of raw materials, intensive in-process control of all manufactured parts and sub-assemblies, as well as final inspection and testing of finished products.
The company’s plant holds GMP (Good Manufacturing Practices) certification, following the standards set by the International Organization for Standardization (ISO). SurgiKart India has successfully implemented and updated its Quality Management System, accredited by Presafe (a DNV GL & NEMKO COMPANY) for ISO 13485:2003/NS-EN ISO 13485:2012 certifications. All SurgiKart India products bear the CE marking, meeting the requirements for distribution and sale in the European Economic Community (EEC). Additionally, the company has obtained USFDA registration for its products, including Infusion Sets, Urine Collection Bags, and Anaesthesia Products, among others.
Explore Our Products
Below you will find the range of medical products that we manufacture and/or deal in:
CARDIAC SURGERY
We specialize in advanced cardiac surgery equipment, meticulously designed for precise care. Our products undergo rigorous quality checks to ensure safety and efficacy. Committed to innovation, we craft cutting-edge devices tailored for healthcare professionals, prioritizing patient well-being and optimal outcomes.
Discover the best in medical device manufacturing with us!
Specializing in OEM and contract manufacturing, we’re your top supplier in India. Contact us now!
Our Company's
Capabilities:
- Skilled personnel specialize in product development with controlled injection molding.
- Services available include R.F Welding and Silk Screen Printing.
- Clean Room of Class 10,000 ensures hygienic premises.
- Assembly services with jigs and fixtures, along with Solvent Bonding and Leak Testing.
- Tipping and Punching services offered.
- Medical Device Packaging services, including pouch sealing and kit packing.
- ETO sterilization services available.
- In-house laboratory for Medical Device testing.
- Over 80% of production exported to 52+ countries.
- An approved supplier for leading Pharmaceutical and Medical Device Companies.