Achievements and advantages / 

Our achievements:

CE registration agent, breaking DNV's fastest certification record in three years and obtaining more than 40 510K zero-defect records, with the fastest project being Class II medical devices approved within 26 days in 2021

SGS's first MDSAP certification coaching

Obtained the registration certificate for the fastest wholesale of Class II medical devices for enterprises in Dongguan City

Took over multiple difficult projects that were transferred from other peers, completed the audit as scheduled, and obtained certification. like the UK Department of Health issues supplementary rectification measures

Coached more than ten companies in FDA factory inspections, five of which passed with zero defects
Adaptive Hearing Aids Receive Nation's First FDA 510K Registration Approval



Our advantages:

Good reputation and high recognition——

Reanny is currently one of the best reputable medical device consulting institutions in Guangdong Province;
We are highly recommended by SGS and TUV SUD to their clients;



Zero failure, Fast certification——

All the cases without any failure, 100% qualified through the audit;

Our multiple FDA 510K zero defect submissions have passed, and the CE certification speed has broken the DNV record in the past three years;

We can help companies obtain certification and go public as quickly, legally, and in compliance, enhancing their efficiency and competitive advantage.;



High end service, super value price——

Provide value for money services at prices lower than peers;

What we provide is not just certification for documents or individual products, but also to help enterprises educate and cultivate some talents, and solve the problem of sustainable operation in the later stage of the enterprise;

We are not only helping you obtain a document, but also informing you of the requirements of medical device regulations and the importance of compliance, reducing the risk of product launch;



Powerful experts and professional technical team——

Reanny maintains close contact with auditors from announcement agencies, laboratory experts, and government agencies to stay informed of the latest regulatory developments and provide the fastest assistance to businesses through analysis;

The consulting team members have an average of more than 10 years of management experience in the medical device industry.



Systematic and comprehensive one-stop service——

We provide a full range of services from product design to certification, covering active, sterile, implantable, in vitro diagnostic FDA, CE, China, Japan, Brazil Canada, Australia and other certifications in more than 20 countries around the world;
The services currently launched include: product design review, system guidance, factory inspection guidance, registration and certification, clinical agency, long-term regulatory consulting, training and education, UDI registration, and other full process services applicable to medical device enterprises;