Shenzhen ROUNDWHALE Company is a newly established enterprise specializing in the production of electrical stimulators such as TENS, EMS, IF, etc.    Due to our general consultant's extensive experience in the stimulator industry, the client's company packaged all the CE, FDA, domestic registration, and system establishment projects for the company's products and entrusted them to our company for guidance at the beginning of its establishment.With our expertise in electrical stimulators and our ability to understand the 510K regulations, we carefully drafted the 510K technical documents and submitted them. Within three months, we passed the FDA approval with zero defects and obtained approval. The K number is K181688This is the second case since 2018 where our company has received 510K approval for zero defects.

Dongguan Jiate Medical Equipment is a professional manufacturer of various disposable dental consumables, and is a subsidiary factory of Wanlian International Co., Ltd.The company was founded in 2002 and has multiple production workshops including injection molding, extrusion molding, tube drawing, blown film, masks, hair sticks, and automatic assembly. It is one of the earliest enterprises engaged in dental instruments in China. Over the years, the company has exported over a hundred types of products to the United States, with a total of 510K products and more than 50 registered items.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 auditor has extensive experience, clear review thinking, and a basic understanding of Chinese. This is a significant challenge for factory audits.The audit is divided into the following itinerary:1) CAPA: CAPA cases, feedback, complaints NCARS2) On site inspection3) Special Process Confirmation4) Design and development5) Supplier file review6) DHR and Inspection Test Procedure7) Production equipment management and maintenance8) Training and Assessment9) Instrument calibration10) Document control management11) Employee interviewsWith 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.After the audit, the FDA auditor highly praised the factory for its excellent performance in process validation, design and development, and CAPA.Due to the good cooperation and professional spirit during the coaching period, after the audit was completed, the client's responsible person approached our colleagues and continued to negotiate and sign the next cooperation project: ISO 13485-2016 version certification.

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.