Medical device inputs include regulations and standards, design, and product direction.
1, regulations and standards
As an example, "magnetic therapy device", need to consider the regulations: registration-related (including instructions), standards (safety, EMC, product line standard, etc.), system standards, such as 13485, risk standards.
In fact, many of these can not be a person can all understand, more is the need to form a written information only, but not completely so, which needs to focus on the line standard and risk, in product development needs to be considered in depth, otherwise it will bring unnecessary losses.
2, appearance design
Medical device design appearance of the input should also include the appearance of the input, and the appearance of the input actually lies in the comparison, compared with peer products, similar products or related products appearance, these are not the necessary input information, but for the product design, reference to the peer product appearance is inevitable, the general appearance of the pure and do not need to refer to, but the structure of the general The design of the product is not a necessary input information.
And the appearance of the product is determined by the structure of the overall situation, so the actual still need to refer to. Therefore, the collection of appearance products is a kind of medical device input information, which is favorable to comparison, reference and reference. Most of the innovations in appearance come from comparison.
3, the direction of product development
This generally applies to medium and large enterprises or can also be suitable for small and medium-sized enterprises, mainly to see whether the product needs to develop abroad, if there is a plan, then the design of the product should be close to the ce certification. First do not have to consider the 13485 system aspects of the certification will meet the requirements of the ce certification, the product itself iec standard than the domestic strong standard and turn the standard to be much newer.
Which projects may be in conflict, this requires certification engineers are very familiar with the regulations and standards, otherwise the design of the product may only meet the domestic strong standard, does not meet the iec standard, then wait until the company has the capital to do foreign projects, apply for the ce, the product needs to be re-designed once again, this is very laborious, waste of costs.
So the direction of product development should be used as an important input information.