Medical device certification is how?

Medical device certification includes 1, product safety certification 2, quality management system certification Medical devices how to obtain the "safety certification mark" The following to obtain CE certification as an example: products to be successfully through the product to be successfully through the product to be successfully through the product to be successfully through the product to be successfully through the CE certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification certification ，，，， need to do a good job in three areas aspects of the work need to do a good job in three aspects of the work need to do a good job in three aspects of the work need to do a good job in three aspects of the work 。。。。 First, the collection and certification of products related to the European Union technical regulations and the European Union (EN) standards, through digestion, absorption, into the enterprise product standards. Second, the enterprise in strict accordance with the above product standards to organize production, that is, the requirements of the above technical regulations and EN standards, implemented into the enterprise product design and development and manufacturing of the whole process. Third, the enterprise must build and maintain quality system in accordance with ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification. For the current EU has issued 18 categories of industrial product directives, from the structure of these directives, they can be divided into vertical directives and horizontal directives. Vertical directives are aimed at specific products, such as the Medical Device Directive; horizontal directives apply to a variety of product series, such as the Electromagnetic Compatibility Directive, which applies to all electrical appliances and electronic parts and components products. For gamma knives, the applicable directives are the fourteenth, the first and the fifth, i.e.: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive and 89/336/EEC Electromagnetic Compatibility (EMC) Directive. (3) EN60601-2-11 Medical Electrical Equipment Part II: γ-beam therapy equipment safety-specific requirements; (4) EN60601-1-2 Medical Electrical Equipment Part I: General Requirements for Safety, Section 1.2 Parallel Standards Electromagnetic Compatibility - Requirements and Testing. Which (1), (2), (3) standard is the basis of the gamma knife low voltage (LVD) test: (4) standard is the basis of the gamma knife electromagnetic compatibility (EMC) test. Class I products to be affixed with the CE marking, can take the way of self-declaration. That is, the manufacturer to prepare the product's technical documentation files, and at the same time, according to the relevant EN standards for product testing or commissioned by the ability to test the laboratory to test qualified. Category a Ⅱ, category b Ⅱ, category Ⅲ products to be affixed with the CE marking, the EU must be designated by the verification body to verify. The EU also provides that these types of products to obtain CE certification is a prerequisite for the manufacturer to be able to ISO9000 + ISO13485 quality system certification, ISO9000 + ISO13485 quality system certification certificate, and the certificate issuer should be recognized by the European Union certification body. ISO9000 + ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be pending. ISO9000+ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be issued only after the ISO9000+ISO13485 quality system certification is passed. (1) the enterprise to the certification body to submit an application for certification, and fill out the certification request for quotation to the certification body; (2) certification body to apply for certification of the enterprise to put forward the quotation, the enterprise signed to confirm that the completion of the contract; (3) the enterprise to the certification body to submit the ISO9000 + ISO13485 quality system documents, namely, the quality manual and procedural documents for the certification body to carry out the audit of the system documents; quality system audit, the enterprise should have at least Quality system audit, the enterprise should have at least three months of quality system operation records, and to complete 1-2 times the internal quality system audit. (4) certification body to issue a certification product test notification form to the certification body accredited laboratories, laboratories will apply for certification of products for low voltage (LVD) test and electromagnetic compatibility (EMC) test. If there is a failure in the test, the enterprise to change down and retest until the test is qualified. The end of the test, the laboratory issued a test report. (5) enterprises to prepare the application for certification of product technical documentation files (referred to as TCF files). The above test report is also used as one of the contents of the TCF file. TCF file is an application for CE certification of the manufacturer to the CE certification body to submit an important document, it is the certification body to audit the important basis for licensing. Preparation of TCF documents must all use English. (6) The certification body conducts a preliminary examination of the ISO9000+ISO13485 quality system and TCF documents of the enterprise. After the preliminary examination, the certification body will point out the problems in the quality system and TCF documents, and the enterprise should improve the quality system accordingly. Consulting. Up to the consulting agency intercepted