Each authorized person

Concurrent positions of person in charge of product manufacturing/person in charge of Japan Quality Industry/Management supervisor/person in charge of management Under the following circumstances, the person responsible for manufacturing the product/Japanese quality industry may also be responsible for the production/management/management. The person responsible for manufacturing the product may also be the person responsible for managing the product, or the person responsible for managing the Japanese quality industry. Person in charge of management of Japan Quality Industry, concurrently serving concurrently. 2 or 3 or more persons may be responsible for the production of the product, and may concurrently serve concurrently as a manager, manager, and Japanese quality industry manager, but each person may be responsible for their own duties. Concurrent positions as Manufacturing Manager/Japan Quality Industry Manager/Safety Management Manager/Technical Manager Under the following circumstances, you may also serve as a production manager/Japan quality industry manager/safety management manager/engineer. The first type of medical equipment manufacturer, the person responsible for manufacturing the same product at the same time, and the person responsible for managing the Japanese quality industry, the second type of medical equipment manufacturer. The person responsible for manufacturing the product may serve concurrently at the same time as the person responsible for the production of Japanese quality, and the person responsible for the safety management may also serve concurrently. 3rd type medical equipment manufacturer, person in charge of production, Japanese quality, and safety management; person in charge of domestic product quality; As a result, the development and development work of the company may be located in the same facility, and may be held concurrently at the same time. Type 1 Type 2 ① Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, education, medicine, and medical trade courses at university or high school. ② Completed physics, chemistry, biology, engineering, informatics, metallurgy, electrical engineering, mechanics, engineering, medical or dental trade courses while in high school, completed quality control of medical equipment or medical equipment, or completed post-market safety management work for more than 3 years. ③ Over 5 years of quality control management of medical equipment or medical equipment, and post-launch safety management training, and personnel training training under the supervision of the Minister of Health, Labor and Welfare, which has been completed. ④ Approved by the Minister of Health, Labor and Welfare. Type 3 ① Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, engineering, medicine, and industrial courses while in high school. ② Over 3 years of experience in high school in interrelated subjects such as physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, engineering, medicine or engineering, as well as quality management of medical products, quasi-medical products, chemical products, or medical equipment, or post-market safety management. ③ Approved by the Minister of Health and Welfare. Japan Quality Industry Management Personnel Requirements Japan Quality Industry Management Personnel Management Medical Equipment Quality Management Industry, and the establishment of the company's equipment and marketing personnel requirements, etc. Because of the quality management industry's demand knowledge and coordination, there is one person who is responsible for the demand leadership. Japan quality industry management staff demand is below the requirements. ① Must be a member of the manufacturer's quality assurance department ② Must have worked in product quality management or other similar industries for 3 years or more ③ Must have the ability to successfully develop and develop quality management in Japan ④ Non-medical equipment, etc., personnel in the electronics department, non-existence, and other possible obstacles to the normal development situation of the Japanese quality management industry. The QMS enforcement notice shall be deemed to have been issued for ``②Product quality management work or other similar work for 3 years or more''. The following refers to the responsible person or person who has worked in the product quality management industry or other similar industry for 3 years or more. In addition, "more than 3 years" refers to the cumulative term of the relevant business operations, and does not apply to the present company or other companies. a. Manager b. Manager c. Person responsible for manufacturing medical equipment, etc. d. Former law office certified quality assurance personnel, production managers and responsible technical personnel. e. Other personnel responsible for production management, quality management, and manufacturing business. f. Current ISO 9001 or ISO 13485 Authorized enterprises, etc. (limited to the production of goods, electronics or production enterprises, non-packaging) Personnel responsible for maintaining and operating the quality management system (including administrative services, service-related enterprises, etc.). Requirements for personnel responsible for safety management Qualification requirements for personnel responsible for safety management for manufacturing, control, and advanced management of medical equipment (III, IV categories) Qualification requirements for personnel responsible for safety management Qualification requirements for personnel responsible for safety management Manufacture, control, and advanced management of medical equipment (III, IV categories) Qualification requirements for personnel responsible for safety management Qualification requirements ① Must be a person in charge of the System Security Management Department ② Must have worked in the security industry or other similar industry for 3 years or more ③ Have the ability to successfully develop and maintain security security ④ There are no non-medical personnel in the air control department, and there are no other possible obstacles to the normal development of Japan's security industry. Manufacture and management of medical equipment (Class II) and general medical equipment (Class I) Safety management personnel Qualification requirements: ① and ② below. ① The ability to ensure the normal development of the security industry. ② The development of non-medical equipment and the absence of other possible obstacles to the normal development of the Japanese security industry. The license for medical equipment, approval, approval, etc. is mutually exclusive, and the system is accessible to us. We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc. Medical equipment application has high level of industry, ability is perfect, and administrative staff is small. We provide medical equipment, medical equipment, legal services, and legal services based on the basis of our production, business, and business agents. Our teams are present in all prefectures across the country. You must receive additional information from our system. All-Japan project for staff management

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First-class medical equipment manufacturer	The person responsible for manufacturing the product and the person responsible for handling the Japanese quality industry may also serve concurrently at the same time.
Second type medical equipment manufacturer	The person responsible for manufacturing the product may serve concurrently at the same time as the person responsible for the production of Japanese quality, and the person responsible for the safety management may also serve concurrently.
Third-type medical equipment manufacturer	May also serve concurrently as production manager, Japanese quality management representative, and safety management representative.
Domestic quality management personnel and technical personnel	The business operations provided by Nyoka Manufacturing Co., Ltd. are located in the same facility.

①	This is the manufacturer's quality assurance department.
②	Over 3 years of product quality management or other similar work
③	Guaranteed Japanese quality management business normal business development ability
4	The absence of non-medical equipment, etc. personnel, and other possible obstacles to the normal development and development of Japanese quality control business.

Concurrent positions of person in charge of product manufacturing/person in charge of Japan Quality Industry/Management supervisor/person in charge of management

Concurrent positions as Manufacturing Manager/Japan Quality Industry Manager/Safety Management Manager/Technical Manager

Manufacturer's personnel requirements

Japan Quality Business Administration Personnel Requirements

Safety management personnel requirements

Qualification requirements for safety management personnel for manufacturing and control of highly controlled medical equipment (III, IV categories)

Qualification requirements for safety management personnel for manufacturing and control medical equipment (Class II) and general medical equipment (Class I)

Licensed medical equipment, approval, approval, etc. are compatible with each other, and we are familiar with the system.

<1>	The person responsible for manufacturing the product may also be the person responsible for managing the product, or the person responsible for managing the Japanese quality industry.
<2>	Person in charge of management of Japan Quality Industry, concurrently serving concurrently.
<3>	2 or 3 or more persons may be responsible for the production of the product, and may concurrently serve concurrently as a manager, manager, and Japanese quality industry manager, but each person may be responsible for their own duties.

Medical equipment manufacturing business	Eligibility requirements
The first Second	①	Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, education, medicine, and medical trade courses at university or high school.
	②	Completed physics, chemistry, biology, engineering, informatics, metallurgy, electrical engineering, mechanics, geology, medicine or other industrial trade courses while in high school, completed work on quality management of medical products or medical equipment, and completed work on safety management after launch. Over 3 years.
	③	The quality control management of medical equipment or medical equipment has been carried out for more than 5 years after its launch, and the training and development of personnel has been completed by the Minister of Health, Labor and Welfare.
	4	Approved by the Minister of Health and Welfare.
Third	①	Completed physics, chemistry, biology, engineering, information, metallurgy, electrical engineering, mechanics, biology, medicine, and industrial courses while in high school.
	②	While in high school, completed interrelated subjects such as physics, chemistry, biology, engineering, informatics, metallurgy, electrical engineering, mechanics, geography, medicine or other fields of medicine, as well as quality management of medical products, quasi-medical products, chemical products or medical equipment, and post-marketing. Over 3 years of experience in safety management.
	③	Approved by the Minister of Health and Welfare.

①	This is the person in charge of the body safety management department.
②	3 years or more of security work or other similar work
③	Safe and secure security operations, successful development capabilities
4	There are no non-medical personnel in the air control department, and there are no other possible obstacles to the normal development of Japan's security industry.