Health Screening Kiosk:Track Your Health Status Anytime Everywhere
It is well-known that Sunson Tech developed from being a pin-pad manufacturer to be a self-service kiosk manufacturer and solution provider for more than 17 years. The health screening kiosk, as one new and typical standard product of Sunson, equipped with unique elegant design, multiple and diversified functions which allows the customer to easily get a primary test results for the basic functions in an easy, interactive and secure way.
SUNSON health screening kiosk can everything people need to facilitate the process of simple health check-up by offering tests for
- Blood Pressure
- Body Temperature
- Oxygen in blood SPO2
That all results listed above attributes to Sunson health screening kiosk is equipped with these main components, and it can be installed in any indoor places such as drug stores, hospitals, government offices, living complexes and supermarkets)
- 15” Capacitive Touch Screen
- Card Reader (3in1)
- Blood Pressure Testing Module
- 80mm Thermal Printer
- IR Height Sensor
- E-Scale for measuring body weight
- BMI Testing Module
- IR Body Temperature
- Movable Chair.
- SPO2 Testing Module
- Width: 840mm , Depth 920mm,
- Height 2020mm
- Weight 160KG
On July 12, 2019, Sunson Tech achieved the MDSAP certification issued by Intertek, becoming the first
medical device manufacturer in the same product industry to receive this certain certification.
From the starting point, Sunson Tech finally passed the two audit for MDSAP certificate within half one year, this new milestone marks our Sunosn Tech's health screening kiosk's design, manufacturing and services are all in accordance with ISO 13485:2016 standard and Canadan Medical Devices Regulations - Part 1 - SOR 98/282's request. This will strongly promote Sunson Tech medical devices' quality management level, especially for both the expansion of the medical treatment apparatus profession and the development of the company have a positive role in promoting.
What is MDSAP?
The MDSAP Medical Device Single Audit Program (MDSAP) is a new set of Audit procedures approved and joined by regulators in the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC) and Japan (MHLW). This procedure aims to establish a single audit process to meet and unify the audit requirements of the countries listed above. Then it can make the audit more comprehensive and effective. The regulatory agencies of the above five countries have recognized the audit results of MDSAP, and the manufacturers can reduce the audit times of different regulatory agencies and reduce the production interference caused by the audit. The MDSAP makes the international medical audit process standardization and reduce the burden of production enterprises.
For MDSAP, it not only reduces the routine inspections procedures of the regulatory authorities, but also allows them
to share the same and reliable audit results. Since the audit results of MDSAP are recognized by the regulatory authorities,
the enterprises can reduce the procedures' number of audits corresponding to different regulatory authorities and reduce the
production interference caused by the audit.
From January 1, 2019, some member states will no longer implement their existing quality management system requirements, but make MDSAP mandatory.
Significance of enterprises passing MDSAP certification
- Meet different national regulatory agencies' QMS/GMP requirements, with this single audit, enterprises can
access to multiple markets.
- Reduce the compliance costs.
- Shorten the market development cycle.
- Promote the enterprise's quality system integration level, improve the level of enterprise management.
Sunson Tech's MDSAP Certification Audit Process
In January 2019, the consulting company participated in the establishment of the MDSAP project, comprehensively interpreted the ISO13485:2016 standard, collected and translated the knowledge of Canadian laws and regulations, organized training and learning for all employees, revised the quality manual and procedure documents, and completed the internal audit of the company in May.
Certification audit stage
On May 13th and May 14th, 2019, Sunson took the first phase of formal audit. From June 17th to 19th, the second phase of formal audit was completed, and the document review and on-site inspection were successfully completed.
Audit closing phase
On July 5th, 2019, Sunson Tech received Intertek's MDSAP audit report. And n July 12th, 2019, Sunson Tech received the official MDSAP certificate.
All colleagues of Sunson Tech are adhering to the concept of "Military design, Rational choice", Sunson improveed the competitiveness of the enterprise through continuous technological innovation, new product research and development. Sunson Tech has passed ISO9001:2015 quality management system certification, and in daily operation management, Sunson Tech strictly in accordance with the quality management system standards. Also Sunson Tech has successively passed a series of honors and product certification issued by National Bank Card Testing Center, National Cryptography Committee, International PCI Security Standards Committee and other institutions. This time, Sunson Tech successfully passed the quality management system certification of MDSAP medical devices, which played a positive role in promoting the development of the company, especially the expansion of the medical devices industry.