What is Design and Development Inputs according to ISO 13485
The ISO 13485 standard requires defining inputs required to complete the development of the medical device. The inputs will be determined according to the design and development activities, and the intended use of the product. The following should be part of the design and development inputs, as it’s required from the standard:
- Function, performance and safety requirements rendering to the intended use
- Applicable regulatory requirements
- If appropriate, requirements derived from previous developments
- Requirements resulting from risk management
- Other requirements (without specifying them in more detail)
Functional and Performance Requirements
To let the identification of needed design and development inputs, the organization is obligated to define the requirements and functionality of the device. The ISO 13485 standard requires functionality, performance, and safety according to the intended use, specified in the following bullets:
- The intended use refers to the purpose, operation, and utilization of the medical device and it is related to patient and user requirements. It may include special requirements regarding the nature of the medical device.
- Physical characteristics of the medical device – dimensions, drawings, plans, diagrams, and samples. The definition will refer to tolerances and limits.
- Requirements for handling and performance with the medical device – specifying aspects like a package, storage, operation, handling, and maintenance requirements
- Definition regarding the working environment of the medical device – the customer must be aware of the medical device that has to be operated under controlled temperature.
- Interface with other devices –If the medical device is to be combined or installed with another medical device or piece of equipment, and/or accessories, it shall be referred as inputs to the design and the development for functionality, performance, or safety.
- Service requirement –If the organization knows the medical device will require service activities in the long term, then the design and development teams must be notified in advance.
- Labeling requirements – a requirement includes a reference for the prevention of predictable misuse of the medical device.
- Toxicity, biocompatibility, or electromagnetic compatibility – a requirement refers to the compatibility of components.
The manufacturer will specify safety requirements needed as inputs for the development. It may affect the design of the device (therefore, it will affect the inputs of design and development.):
- Functionality and intended use: What are the operation instructions? Is there any special guidance? What is the functionality of the medical device? Are there any risks related to the use? Where will the device be used for? Who is to operate the device? Who is the target group that will use it? Is the device intended to be used with other devices?
- Performance: What is the energy requirement of the medical device? Are there any special restrictions or limitations? How long is the expected shelf life? Are there any service or maintenance necessities? What may influence the device and its performance?
- Safety: Does the device present any risk to the user, operator, or the environment? Does the device have special requirements, like sterilization or storage? Do any special measures need to be applied before, throughout, or after? Do certain conditions influence the materials?