Do you want to compromise with the quality and compliance of medical devices for cost-saving purposes? The answer should be no. In today's rapidly changing healthcare landscape, using the best quality medical devices must be non-negotiable. Surgical institutions, hospitals, and healthcare institutions always seek medical devices that are not only beneficial for patient safety but also pass through all regulatory frameworks.
SI Surgical is a leading medical device manufacturer in Kolkata that maintains all international standards, including the ISO 13485 medical devices quality management system, to ensure the best quality medical instrument. From design to production, we maintain all safety standards regarding the production of best-quality medical devices. Through this blog, we will discuss how SI Surgical meets global healthcare standards regarding cutting-edge quality and compliance in medical devices to ensure safety.
What Do You Mean by Global Standards for Medical Devices?
Medical devices, which are essential for operation theaters and regular monitoring of patient's health, should meet all international and national regulations. Let's discuss them in detail-
NABH (National Accreditation Board for Hospitals & Healthcares)—It is India's premier accreditation body that sets the guidelines for OT design, patient safety, and infection control.
WHO guidelines – This international guideline is mainly applicable to surgical safety checklists, sterilization protocols, and prevention of infection.
ISO 13485 – This global medical standard ensures the quality management system for the manufacturing of medical devices.
CDC & Joint Commission International standards – This global standard in medical devices mainly covers surgical site infection prevention, sterile processing, and maintaining air quality.
SI Surgical mainly follows all types of national and international standards regarding the manufacturing of essential medical devices and OT instruments for hospitals in India and outside India.
How Does SI Surgical Ensure Compliance with Medical Device Manufacturing?
SI Surgical mainly follows all types of safety compliance regarding the manufacturing of OT instruments and other medical devices. Let's discuss them in detail-
NABH related design
SI Surgical mainly follows a seamless design architecture to prevent contamination of medical devices.
Antibacterial powder-coated panels in medical devices mainly reduce the microbial load in surgical instruments.
Selection of material for safety and durability
Insulated panels are fire-resistant and easy to disinfect.
Hermetically sealed doors can minimize air leakage and maintain a standard air pressure.
Significance of Infection Prevention for Medical Devices
Taking preventive safety precautions regarding infection prevention in medical devices must be a huge concern for global medical society. SI Surgical always maintains all types of safety precautions regarding infection prevention for medical devices. Let's discuss this-
WHO's SSI prevention mainly focuses on proper guidelines regarding sterile instrument handling and maintaining antibiotic protocol.
Automated sterilization zones mainly ensure that all instruments pass through a contamination-free environment.
SI Surgical mainly provides essential training to its staff regarding annual maintenance contracts to ensure the sustainability of all medical devices and OT instruments.
Reasons for Choosing SI Surgical
If you are searching for a medical device manufacturer for the best quality OT instruments and other medical devices, you must choose SI Surgical for the following reasons:
20+ years of expertise – We have a reliable track record of manufacturing medical devices as per the NABH and WHO standards for OT solutions.
Sustainable practice – We maintain sustainable practices regarding the reduction of manufacturing waste through an effective recycling process.
Cutting-edge service – From design to production, we follow all types of certification programs to ensure cutting-edge service.
IoT-enabled controlling devices – We are trying to introduce all the latest technology in the manufacturing of medical devices and OT instruments. Automated lighting, airflow adjustments, and temperature control are the latest surgical features that you can get from us.
Conclusion: SI Surgical never compromises with quality over price. Our commitment to maintaining global healthcare standards should be constant. We ensure safety, sterility, and surgical excellence in every medical instrument. If you are planning to upgrade your hospital with new medical instruments, you must contact SI Surgical for international standards enabled medical devices and OT instruments.
