How can I write a good medical device product technical report?

Requirements for medical device product technical reports

The product technical report should be able to support the product standard, safety risk analysis report, clinical trial data, medical device specification and other related content, and other related documents have consistency. Application for registration of the product design and development and development process, must be effectively controlled.

The contents of the medical device product technical report

1, product features, working principle, structural composition, intended use

a) Product features: including the source of the project, the product's mechanism and principle of action, the product's technical characteristics, performance characteristics, characteristics of the use of the product;

b) Working principle: including the product as a whole and the working principle of each part (to be attached to the schematic diagram) and description ( Including electrical? gas, mechanical, software, etc.);

c) structural composition: should be able to reflect the product as a whole and part of the structural composition and shape of the pattern;

d) intended use: including the expected scope of application, expected adverse reactions and contraindications;

e) the same unit of registration contains several specifications or models, should be detailed in the above content.

2, product specifications or the main performance requirements to determine the basis

a) product specifications or main performance indicators: including product performance and safety performance related to the main technical indicators or performance indicators;

b) the basis for determining: product performance related to the main technical indicators or performance indicators.

3, product design control, development, research and development process

a) product design program;

b) product design instructions, calculation formulas and instructions on the calculation method;

c) the process of solving the key technical problems, including the technical routes and methods used, as well as the process of solving the problem and the results;

d) product safety risk control, including according to the The intended use of the product and the use of error can be foreseen risks and precautions taken in product design and manufacture, as well as the protection of operators, users and product safety measures, as well as the results of the risk control;

e) product design verification, including the implementation of the verification of the process of product design and methodology used, as well as the results of product verification and design improvement measures;

f) the development of registered product standards, including relevant technical standards and technical indicators to determine the basis for the search, as well as the verification of registered product standards and standards for product quality control, as well as the evaluation and review of registered products.

4, the product's main process and description

a) the enterprise product production of existing resources and quality management capabilities of the overview of the situation, including production sites, production equipment, inspection equipment, personnel, etc.;

b) product process or flow chart, need to specify the outsourcing of processing processes;

c) process description of the important processes;

d) the main raw materials, spare parts, and product quality control, and the review and review of registered products. p> d) the supply of major raw materials, spare parts and components.

5, testing and clinical trials

a) product testing;?

b) The clinical trials or validation of the product.

6, comparative analysis with similar products at home and abroad

a) an overview of the technology and the development of domestic and international overview;

b) the market situation analysis.

Key points of the medical device product technology report

The report should include the following points.

1, product characteristics, working principle, structural composition and intended use;

2, product technical indicators or the basis for determining the main performance requirements;

3, product design control, development and development process;

4, the product's main process and description;

5, product testing and clinical trials;

< p> 6, comparative analysis with similar products at home and abroad.