SHENCHEN ROUNDWHALE is a newly established start-up company that mainly produces Class II electrical stimulators.For new businesses, time equals money equals opportunity. So customers are very eager for early certification. Based on respect and support for entrepreneurs, our general consultant personally took charge of this project -510K registration. After a month of organizing and preparing the submitted materials, it was submitted to the FDA in early March. Based on our expertise in stimulators and 510K, this case passed FDA review with zero defects and received approval letter in May.During this period, the FDA sent an email highly praising our company's professionalism.After obtaining the certificate, the customer promptly receives the company's [sensitive word] US orders, taking the [sensitive word] step towards enterprise sales.Therefore, the customer expressed high appreciation and gratitude to our company. At the same time, both parties further signed a cooperation agreement for the CE and FDA projects.

Shenzhen Pukang Medical is a professional enterprise engaged in household medical equipment, with main products including thermometers, breast pumps, and blood pressure monitors.Based on commercial needs, we have signed a 510K registration project for our thermometer product.After more than a month of document preparation, we have submitted the registration application. Due to the small scale of the client, the product is developed by external solution providers.It was difficult to provide documents in the early stages, so our consultants patiently guided the clients, providing sample essays and explanations. Ensure timely completion of relevant documents.After submission, obtain FDA 510K approval within 6 months of the normal FDA cycle.

Shenzhen Jingkehui is a specialized manufacturer of OTC electrical stimulators, which includes design, manufacturing, and sales processes. North America is the main market for customers, and FDA factory audits are crucial for them.Due to the successful cooperation experience with CE in the early stage, the customer did not hesitate to deliver the coaching contract for FDA factory inspection to our company.After initiating the coaching, our company provided a lot of support in training, program modification, record coaching, case analysis and support, and difficult point tackling, enabling the client to complete all the audit preparation work before the audit.The auditor who came to audit is an African American auditor from the United States, who works very seriously and has a very clean character.Through the full cooperation of both parties, the 4-day review was successfully passed.During the coaching and review process, both parties further consolidated their trust in cooperation, laying a solid foundation for long-term annual services in the future.

Shenzhen Pukang Medical Equipment Co., Ltd. is a Class II medical device manufacturer specializing in the production of electronic thermometers, infrared thermometers, and breast pumps. The company has been applying for CE certification since 2017, and the notified body is CE0598After obtaining ISO 13485 quality system certification approved by SGS 0120, the company submitted CE registration applications for electronic thermometers and infrared thermometers.During the audit, SGS Finland assigned German auditors to audit TCF and Finnish clinical doctors to audit CER.At the professional level of CE TCF writing in our company, we passed the auditor's review in a timely manner and finally successfully obtained the CE certificate.

Dongguan Yasi Electronics is a professional enterprise engaged in the development, production, and sales of beauty equipment. Its products are mainly sold in the United States, Japan, and South Korea, and are very sensitive in the industry.Due to the certification renewal requirements of ISO 13485-2016 and the QSR 820 system requirements of brand customers, the customer has initiated a request for ISO 13485 version renewal+QSR 820 system coaching and certification.After being introduced by NB and friends, the customer chose our Shenzhen Ruienni Medical Device Management Consulting Co., Ltd.After conducting face-to-face interviews, corporate assessments, and evaluations of brand clients, we officially signed a cooperation agreement with Shenzhen Ruini Medical Device Management Consulting Co., Ltd. on the spot.

Dongguan Jinyang Electronics (Netop) is a Hong Kong funded manufacturer specializing in the production of beauty equipment and LED phototherapy medical devices. The LED phototherapy medical devices applied by the company were found to have a series of non conformities during the CE certification review.The main issues are:1) Risk management report;2) Clinical evaluation report;3) Instructions, etcThrough the introduction of a friend, we have expedited the negotiation between both parties and provided the customer with rectification (to be completed within 30 days).Through our professional analysis and diagnosis, we completed the rectification within 30 days and passed the CE audit closure.