Dongguan Jingfeng Precision Electronics Co., Ltd. is a professional manufacturer of various active dental medical equipment products such as dental photopolymerization, high/low speed mobile phones, polishing motors, etc.The company was established in 2015 and has CNC, post-processing, assembly, and sandblasting processes.After signing the cooperation agreement, our company tailored a consulting plan based on the actual situation of the client. In the process of coaching, we conduct training, program revision review, document and record creation coaching and review module by module.Due to the poor foundation of the client, in order to achieve the goal of approval, we have exceeded the contract period by more than a week to continue providing coaching to the client.The auditor is a South American FDA auditor with 25 years of experience in factory inspection and auditing, and a deep understanding of Chinese culture.The audit is divided into the following itinerary:1) Factory inspection2) CAPA: CAPA cases, feedback, complaints NCARS3) Special Process Confirmation4) Design and development5) Supplier file review6) DHR and Inspection Test Procedure7) Instrument calibrationWith careful preparation in the early stage and timely response and handling on site, the factory passed the FDA factory inspection smoothly after a four-day audit.

Shenzhen Huisike Electronics is a professional manufacturer of various body fat scales and electronic scales. The company has been in operation for many years and currently has more than 700 employees. It is one of the top three body fat scales in the industry.Based on the 2014 FDA factory inspection cooperation, the company has continued to hire our company as a consultant for the MDSAP certification.This tutoring will be carried out by our company's general consultant. After the contract is signed, both parties will negotiate a consulting plan.We strictly follow the plan and have implemented regulatory training, response requirements, document revisions, template provision, and record review services for our clients.The issuing agency for this audit is SGS 0120, and the audit period is 7 audit days.Our company's general consultant accompanied us throughout the entire audit process. Based on good guidance and preparation in the early stage, as well as excellent on-site response capabilities, we successfully passed the MDSAP certification audit. So far, this is the 9th enterprise that our company has successfully passed the MDSAP certification for coaching.After the audit was completed, the inspector claimed that there were zero defects at levels four and five, with only 10 minor defects below level three.Among them, there are 5 issues caused by human negligence of the client company, such as failure to indicate allowable errors on drawings, failure to establish an electronic record list, and failure to conduct risk management for PMS collection results as required.The details and attention to detail of the overall audit of MDSAP are much stricter than FDA factory inspections, and planning is a key task when preparing MDSAP.So for companies that need to prepare for MDSAP certification, they must pay attention to choosing a suitable consulting company.

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.