MDSAP Certificate Obtained by Daan Gene!

On 16th May 2022, Daan Gene obtained the MDSAP (Medical Device Single Audit Program) certificate, which can promote the international presence of our comprehensive solutions and maintain high-quality standards of our processes and services.
Obtaining MDSAP helps streamline Daan’s process of obtaining access to new markets. The certification is considered evidence of a medical device manufacturer's commitment to product quality and regulatory compliance. It also marks a significant achievement, offering Daan Gene an advantage in promoting our high-quality IVD products and selling them to the world market. Daan Gene has always focused on the quality system right from its inception. We have 2,000㎡ GMP certified 10,000-100,000 class clean workshops and we strictly comply with the requirements and processes of ISO13485 for R&D, manufacturing, and service products. Our products are also NMPA and CE certified.
Daan Gene has always been committed to safeguarding human health and fulfilling our corporate social responsibility. In the future, we’ll continue to help create sustainable well-being societies committed to achieving equitable health now and for future generations.
The Medical Device Single Audit Program allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. It includes the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA). 
  • +86 16602030197
  • +86 20 32068126
  • marketing@daangene.com; orders@daangene.com
  • No.19, Xiangshan Road, Science Park, High & New Technology Development District, Guangzhou, Guangdong, P.R. China
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