At SIT,Medical device inspection is a process to verify compliance with regulations and ensure patient safety and product quality. Inspections can occur at different stages, such as pre-shipment, pre-approval for new products, or routine compliance checks. They involve verifying documentation, assessing quality management systems, and inspecting manufacturing processes, facilities, and finished products to meet standards like Good Manufacturing Practice (GMP,FDA).

Key Types of Inspections from SIT

> Routine Inspection: Regular inspections to ensure ongoing compliance with regulations.
> Pre-Approval Inspection: Conducted for new products to ensure the facility can manufacture the product consistently and that the submitted data is accurate before the product can be marketed.
> Compliance Follow-up Inspection: Verify that deficiencies or issues previously cited are fully corrected.
> For-Cause: Triggered by specific concerns, such as adverse event reports or complaints, to investigate and correct problems quickly.
> Pre-Shipment Inspection: Performed before products are shipped to check for quality and compliance with specifications.

Why Inspections are Conducted？

> Regulatory Compliance: To ensure the manufacturer follows federal and international laws and guidelines.

> Patient Safety: To verify the device is safe for its intended use.

> Product Quality: To ensure the device is manufactured consistently and meets the required quality standards.

Solution We Offer Inspection

Diagnostic Equipment:

Medical imaging machines: Radiography, X-Ray Machine, Computed Tomography (CT scan), Magnetic Resonance Imaging (MRI), Ultrasound, and Echocardiography etc.

Durable Medical Equipment (DME):

Electric wheelchairs, Hospital beds, Walkers, crutches, canes (mobility assistive equipment), Traction equipment, Pressure mattresses, Insulin pumps, Breast pumps, Nebulizers, Patient Lifts, Bili lights and blankets, Kidney machines, Stationary or portable oxygen tanks, Oxygen Concentrators Ventilators etc.

Treatment Equipment:

Infusion Pumps, LASIK Surgical Machines, Medical Lasers, and Diagnostic scopes etc.

Life Support Equipment:

Heart-lung Machines, Medical Ventilators, Dialysis Machine, and Incubators etc.

Medical Laboratory Equipment:

Blood gas analyzers, Chemistry analyzers, Blood collection supplies, Electrolyte analyzers, Differential counters, Drug testing analyzers, Coagulation analyzers, Hematology analyzers, Urinalysis analyzers and Microbiological systems etc.