How Do I Get Medical Technician Certification?

CE certification is the European Union's product safety certification. All medical devices entering the EU market must be CE certified for medical devices. The CE directives that medical devices need to meet are the Active Implantable Medical Device Directive (AIMDD, 90/385 / EEC ), The Medical Device Directive (MDD, 93/42 / EEC) and the In Vitro Diagnostic Device Directive (IVDD, 98/79 / EC).

CE certification for medical devices

CE certification is the product safety certification of the European Union. All medical devices entering the EU market must be CE certified for medical devices. The CE directive that medical devices need to meet is "Active

The following is an example of obtaining CE certification:

To successfully pass the CE certification of products, three aspects of work are required.

First, collect EU technical regulations and European Union (EN) standards related to certified products, and digest, absorb, and incorporate them into enterprise product standards.

Second, the enterprise organizes production strictly in accordance with the above product standards, that is, implements the requirements of the above-mentioned technical regulations and EN standards into the entire process of product design and development and manufacturing.

Third, enterprises must establish and maintain a quality system in accordance with the ISO9000 + ISO13485 standards and obtain ISO9000 + ISO13485 certification.

General procedure for obtaining CE mark

At present, some domestic medical device manufacturers (especially some township and village enterprises) do not know much about the medical device directive and do not know how to apply.

There are currently several types of CE certificates:

(1) Declaration of conformity / Declaration of compliance. This certificate is a self-declaration and should not be issued by a third-party agency or testing and certification agency. Therefore, you can use the EU s "Conformance Declaration" "instead.

(2) Certificate of compliance / Certificate of compliance. This is a declaration of conformity issued by a third party agency = (intermediary or testing and certification agency). It must be accompanied by technical information such as a test report, TCF. If there is no test report, Can be handled by a third party agency. At the same time, the enterprise must also sign the Declaration of Conformity.

(3) EC Attestation of conformity. This is a certificate issued by the Notified Body of the European Union (Notified Body). According to EU regulations, only NB is eligible to issue an EC Type CEE statement. This certificate Can be used for customs clearance as a one-time certificate

Gamma knife CE certification should comply with EU technical regulations and EN standards.

Regarding the 18 types of industrial product directives issued by the European Union, from the perspective of the structure of these directives, they can be divided into vertical directives and horizontal directives. The vertical directive is targeted at specific products, such as the medical device directive; the horizontal directive is applicable to various product series, such as the electromagnetic compatibility directive, and it applies to all electrical and electronic component products.

For the Gamma Knife, there are fourteenth, first, and fifth applicable directives, namely: 93/42 / EEC Medical Device Directive, 73/23 / EEC Low Voltage (LVD) Directive, and 89/336 / EEC Electromagnetic compatibility (EMC) directive.

The EU standards supporting these directives are:

(1) EN60601-1 medical electrical equipment Part 1: General requirements for safety;

(2) EN60601-1-1 Medical Electrical Equipment Part 1: General Safety Requirements and No. 1 Amendment;

(3) EN60601-2-11 Medical electrical equipment Part 2: Special requirements for the safety of gamma beam therapy equipment;

(4) EN60601-1-2 Medical electrical equipment Part 1: General requirements for safety Section 1.2 Parallel standard electromagnetic compatibility-requirements and tests.

The standards (1), (2), and (3) are the basis of the gamma knife low voltage (LVD) test: the standard (4) is the basis of the gamma knife electromagnetic compatibility (EMC) test.

Gamma knife CE certification procedures and contents:

The European Union classifies medical device products into four categories, namely: Class I, Class IIa, Class IIb, and Class III. Class I products need to be affixed with the CE mark and can be declared by themselves. That is, the manufacturer compiles the technical file of the product, and at the same time tests the product according to the relevant EN standards or entrusts a competent laboratory to pass the test. If the products of Class IIa, Class IIb and Class III are affixed with the CE mark, they must be verified by a certification body designated by the European Union. The European Union also stipulates that the prerequisite for these types of products to obtain CE certification is that the manufacturer must be able to pass the ISO9000 + ISO13485 quality system certification, obtain the ISO9000 + ISO13485 quality system certification certificate, and the issuing unit of the certificate should be a certification body recognized by the EU. The ISO9000 + ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be issued after the ISO9000 + ISO13485 quality system certification is passed.

According to the European Union's classification of products, gamma knives belong to Class IIb. The CE certification procedures and contents are as follows:

(1) The enterprise submits an application for certification to the certification body, and fills out a certification inquiry form and submits it to the certification body;

(2) The certification body submits a quotation to the enterprise applying for certification, and the company signs the confirmation to complete the contract;

(3) The enterprise submits the ISO9000 + ISO13485 quality system documents, that is, the quality manual and procedure documents, to the certification body for the system documentation review by the certification body; before the quality system review, the enterprise shall have at least three months of quality system operation records and complete 1 -2 internal quality system audits.

(4) The certification body issues a certification product test notice to a testing laboratory recognized by the certification body. The testing laboratory will perform low voltage (LVD) testing and electromagnetic compatibility (EMC) testing on the product applying for certification. If any failure occurs during the test, the enterprise will change the test and retest until it passes the test. After the test is completed, the laboratory issues a test report.

(5) The enterprise compiles the technical file archives (referred to as TCF files) of the products applying for certification. The above test report is also one of the contents of the TCF file. The TCF file is an important document submitted by the manufacturer applying for CE certification to the CE certification body, and it is an important basis for the certification body to review and issue the certification. All TCF documents must be prepared in English.

The TCF file includes seven aspects:

introduction;

Product specifications;

The contents of the main files of the design;

Risk analysis and assessment;

Test report and clinical diagnosis data;

Control of document design;

Declaration statement of product application.

(6) The certification body conducts a preliminary review of the company's ISO9000 + ISO13485 quality system and TCF documents. After the initial audit, the certification body will point out the problems in the quality system and TCF documents, and the enterprise should improve the quality system and TCF documents accordingly.

(7) The certification body formalizes the audit of the company's ISO9000 + ISO13485 quality system and TCF documents.

(8) After the formal review is passed, the certification body will sign a framework agreement with the enterprise, which clearly states that after obtaining the CE certificate, the parties should follow the principles and the scope of the product using the CE mark, as well as how to handle complaints. Then issued ISO9000 + ISO13485 quality system certification certificate and CE mark certificate.

The TOPMEN joint announcement agency SNCH provides comprehensive medical device product certification services for domestic companies, in order to meet the EU CE requirements. At the same time, we will make full use of our international platform to provide more comprehensive services for medical device companies.

We use different certification models to provide certification services for manufacturers of different medical device products, including:

1. Product classification judgment

2. Enterprise technical file assistance

3. Business management assistance

4. Product testing

5. Factory audit (if applicable)

6.CE certificate issuance

1. A global multinational company headquartered in the United Kingdom; with offices in 56 countries around the world, with more than 30,000 registered customers of all types;

2. Asia-Pacific headquarters is located in Shanghai, providing fast, professional and trustworthy services to customers;

3. Technical experts have long been involved in the research and formulation of European regulations and decades of product and system certification experience, providing customers with one-stop solutions;

4. The certified products involve various types of medical devices, and the number of certified customers exceeds 300;

5. Open and impartial certification service process to ensure customers' full monitoring.

At present, we have localized testing and auditing, that is, all testing and auditing will be carried out in China, and domestic staff will save the cost and testing cycle of the enterprise.

(1) Product instruction manual.

(2) Product technical conditions (or enterprise standards), establish technical data.

(3) Product electrical diagram, circuit diagram, block diagram.

(4) List of key components or raw materials (please choose products with European certification mark).

(5) A copy of the certificate of the complete machine or components.

(6) Other required materials.