Certificate & Regulatory

Vincent Medical aims at continuously striving for the optimal product quality in our manufacturing process. With a view to achieving the highest-possible standard, we put massive resources in incorporating a variety of quality systems to our manufacturing process, in order to ensure that our products attain desirable levels.

  • ISO9001
  • ISO13485
  • ISO14971
  • U.S. FDA
  • PRC SFDA
  • Japan MHLW
  • HK DH
  • U.S. GMP (21 CFR Part 820)
  • C-TPAT
  • EC Directive 93/42/EEC

Quality Control and Assurance

Vincent Medical develops its own quality control and assurance procedures to optimize our compliance to regulations. Our comprehensive quality assurance program include:

  • Injection mold qualification and validation process
  • Incoming inspection and monitoring of all raw materials
  • In–process monitoring and verification of manufacturing process
  • 100% FQC and sampling OQA and testing
  • Rigid compliance to documentation of customers
  • Adhere to ISO9001 and ISO13485 quality systems