The development phase of a medical device is a very rigorous process, depending on the classification of the device product.
For example: a class of devices do not need to make clinical trials, such as the manufacturer has a complete test equipment in addition to biological evaluation, you can issue their own registration test report.
Class II devices, according to the risk level of the product and the SFDA and related regulations (CE, FDA, CMDCAS) to determine the requirements, some Class II devices can be exempted from clinical trials.
Class III devices are currently subject to clinical trials, and the design and development of Class III devices is the most rigorous.
The design and development of three types of active devices, for example, is generally divided into the following stages:
Design and development plan, design input, design review, design verification, design confirmation, design conversion, design changes, etc.
1, planning The stages of design and development should be determined for each stage of the review, verification, validation, and design conversion and other activities, should be identified and determined. The activities and interfaces of design and development of each department should be identified and determined, and the responsibilities and division of labor should be clearly defined
2, design input (regulatory requirements, performance requirements, environmental requirements, customer requirements, functional performance requirements, electrical safety requirements, use requirements, environmental requirements, packaging requirements, risk identification, etc.)
3, design output (product drawings, self-assessment reports, biological evaluation reports, basic performance checklists, clinical reports, product registration)
3, design output (product drawing, self-test reports, biological evaluation reports, basic performance checklists, clinical reports, product registration) Checklist, clinical report, product registration full performance test report, etc.)
Related output documents and records; DHR, DHF, DMR
4, Conversion
5, Evaluation
6, Verification
7, Confirmation,
8, Change
9, Risk Management
4-9 There are specific instructions, if the brother really need to contact again in Baidu HI. Friends, the above is just a general summary. If you need a deeper understanding of product development, it is recommended that you study ISO 13485 and FDA regulation Part 820-Quality system regulation. The above is for reference only!