Company Introduction / 

Reanny Consulting Group is a professional, focused, and dedicated service enterprise in the medical device industry, providing comprehensive and comprehensive consulting services. According to its business attributes, it is divided into consulting business line (consisting of Shenzhen Reanny, Reanny (Guangzhou), and Reanny Partnership), clinical business line (Guangzhou Hi-medical), and sister enterprise Hunan Boshu (Medical Device and Drug SMO Agency). We provide one-stop full process services for medical device customers, including GMP factory planning, design review, quality system guidance, clinical CRO, product entry registration (China NMPA, EU CE, US FDA, Canada MDL, Japan/South Korea and Brazil registration), professional course training, UDI agency, long-term consulting services, regulatory representatives, PRRC part-time, and post market factory inspection guidance.
The predecessor of Reanny Consulting Group was Shenzhen Reanny. Currently, it is one of the few consulting companies in Guangdong Province that relies on reputation and technology to operate. Its clients are widely distributed in the Pearl River Delta, Yangtze River Delta, Beijing and other regions. We have served hundreds of customers, over a thousand product cases, and no history of failure!


Service philosophy and commitment

Business philosophy: Honest cooperation, sincere service, comprehensive system, professional and experienced!
Service Policy: We achieve our customers with professionalism, and our customers achieve us with word-of-mouth!



Our team members include professional personnel from medical device companies and third-party laboratory institutions with rich technical and management experience in the enterprise, including management representatives, regulations, research and development, auditors, and laboratory testing. Only serving the medical device industry, because of focus, focus, and because of focus, professionalism!

Due to the experience of medical device enterprises, they have strong capabilities in practical management such as process confirmation, inspection and testing, risk management, and clinical evaluation. Our consulting plan will be tailored to the actual situation of the enterprise, making it easier to implement and implement.

Our company's consulting and expert teams have a professional background in senior management positions and senior medical device certification audits in large and medium-sized medical device manufacturing enterprises; Proficient in the operational modes and characteristics of medical device manufacturing enterprises, different from traditional theoretical consulting enterprises; Proficient in relevant laws and regulations, management standards, technical specifications, and guidance guidelines, possessing significant advantages in regulatory guidance, standard understanding, product testing, document writing, product improvement, professional translation, and practical management. Our team has twelve years of experience in regulatory and system management in medical device enterprises, and understands the enterprise better than our peers and the profession better than the enterprise! In cooperation, Reanny Consulting always provides customers with more services.

We have good cooperative relationships with well-known international certification bodies from countries such as the UK, Germany, France, Finland, and domestic authoritative certification/testing institutions (such as Shenzhen HTW, Huace CTI, Standard Inspection STC, Shanghai Passive Testing Center, Shandong Desheng Biotechnology, Shenzhen SMQ), and can receive advanced information and in-depth technical assistance.

 
Over the years, we have served hundreds of customers. With sincere service, attentive guidance, and profound internal skills, we have successfully served one enterprise after another, and gained unanimous recognition from both new and old customer groups through our oral beer. Our service tenet is: we provide not only certification for documents or individual products, but also to help enterprises educate and cultivate talents, and solve the problem of sustainable operation in the later stage. As a professional consulting agency in the medical device industry, with outstanding technology, we strive to follow our dreams and move forward!

We can provide comprehensive solutions for medical device and electromechanical manufacturing enterprises, including product process design, clinical trials, product testing, technical evaluation, clean plant design and construction, as well as helping enterprises apply for production licenses, business licenses, product registration licenses, and various domestic product entry permits (EU, US, Canada, etc.).

 
Our service tenet is to improve the level of enterprise management, enhance the brand image of the enterprise, train talents for the enterprise, and help the enterprise solve export bottlenecks; With the most professional consultants and the highest quality sincere service, we assist you in achieving your goals.