ISO 13485:2016 certified medical device manufacturer
The certificate
A copy is supplied with every quotation on request. You can confirm the certificate with the registrar directly.
Verify with the registrar- Standard
- ISO 13485:2016, medical devices, quality management systems
- Certificate number
- UQ-30465
- Issued by
- QAC Management Pvt Ltd (UKAAB accredited)
- Holder
- Smart Medicure, Surat, Gujarat, India
- Scope (as printed)
- Manufacturer of Decompression & Flexion Distraction Table, Drop Table, Chiropractic Table, Spinal Scope, Adjusters, Physio EMG NCV, Cryotherapy, Software and Mobile Application
From drawing board to your clinic
- 1
Design and development
Each table is planned, prototyped and load-tested before release. Changes are documented under the quality system.
- 2
Manufacturing
Welding, powder coating, upholstery and assembly follow controlled work instructions with in-process checks.
- 3
Distribution
Units are inspected, fully packed and shipped to your door or port.
- 4
Servicing
Warranty, spare parts and phone support are handled by the same team that builds the tables.
About the certification
What is ISO 13485:2016?
ISO 13485:2016 is the international standard for the quality management systems of medical device manufacturers. It requires documented control of design, production, distribution and servicing, so every unit is built and recorded the same way.
Is Smart Medicure ISO 13485 certified?
Yes. Smart Medicure's quality management system is certified to ISO 13485:2016 under certificate UQ-30465, issued by QAC Management Pvt Ltd (UKAAB accredited).
How can I verify Smart Medicure's certificate?
Check certificate UQ-30465 with the registrar, QAC Management, on its website, or ask Smart Medicure for a copy with your quotation.
What does the certificate cover?
In the certificate's words: "Manufacturer of Decompression & Flexion Distraction Table, Drop Table, Chiropractic Table, Spinal Scope, Adjusters, Physio EMG NCV, Cryotherapy, Software and Mobile Application", for Smart Medicure in Surat, India.
Is ISO 13485 the same as a CE mark or FDA clearance?
No. ISO 13485 certifies the manufacturer's quality management system. Product approvals such as CE marking or FDA clearance are separate and depend on the market, so ask Smart Medicure which documents your country requires before you import.
Built to be safe near patients
- Materials
- Powder-coated mild-steel frames rated to 200 kg, double-layer foam cushions and wipe-clean Rexine upholstery.
- Patient safety features
- An emergency stop and high/low voltage protection on the robotic decompression table, a patient emergency stop on the SMK-90, belting for secure positioning on the decompression systems, and wheels with brakes on the drop and decompression tables.
- Made in India
- Every table is produced in our Surat facility, which lets us control quality, keep spare parts in stock and deliver in 15 to 30 days.