gmp    DNV ISO13485   cqc  TAF Ilac

 

Sunder quality system relies on a strict manufacturing practice (GMP) and conform to ISO13485 and comply with the EEC93/42 directive on medical devices audited by DNV. More highlighting to our reliability, our main items of hemodialysis blood tubing sets and A.V. fistula needle sets obtained us FDA 510(k) pre-market notification, and several items are pending to apply. Most of our manufacturing items are also obtained CE mark as well as other countries’ certification like SFDA of China and KFDA of Korea.

 

If necessity is the mother of invention, innovation should be the engine of growth. To keep pace with the ever changing needs of a rapidly growing market for medical devices, Sunder has set up a fully staffed and equipped R&D section to design and develop new and innovative products onstantly. To keep the research competence, our RD center uses the most top facility like Auto CAD, Pro-E, and UG to assist any creation. For the purpose of verifying all necessary bio-ompatibility, physical and chemical test, Sunder invests lost of expense to build up a national class laboratory. Cumulating with excellent talent as well as the advanced facility, our RD center uarantees to supply our customers with products and services of the highest applicable quality.

 

Consistent high-quality and defect-free production is always the essential and critical request in medical products. Aware of this mission, our attitude toward quality can be summed up in one ord of uncompromising and carry out to our quality policy of “ Top Quality, High reliability, Most cellent”. Sunder’s quality control system executes a comprehensive and exhaustive series of isual, physical, chemical and bacteriological tests and inspections at each stage in the production cycle, from constant surveillance of raw material to final products as well as after-sale. That means our TQM (total quality management) is not only for products itself but also wholesale and service cycle.

 

GMP EN 109.10.29           ISO13485 2021.11.17 

 

CQC14007118585SD S01 2019.12.12           CE SUNDER BTS 2020.02.21

 

CE SUNDER AVF 2021.03.13           TAF S