Medical Device Design Regulations.

The “Design input” requirements.
Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.
The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.
The design input requirements shall be documented and shall be reviewed and approved by designated individual(s).
The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

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Design Input Comment.
Design input is the starting point for product design. The requirements which form the design input, establish a basis for performing subsequent design tasks and validating the design. Therefore, development of a solid foundation of requirements is the single most important design control activity.
Incomplete requirements can have an adverse impact on the design process.
If essential requirements are not identified until validation, expensive redesign and rework may be necessary.

Medical Device Design Regulations

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Concept documents versus design input.
Marketing memoranda and customer concept documents are intended to act as the basis for a design. The intent is for a product conceptual description to be elaborate, expanded and written with an engineering level of detail.

Research and development.
Should not equate prototype design with finished product design.

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Responsibility for design input development.
Product developers need to understand the auxiliary issues that must be addressed, as well as the level of detail necessary to design a product.
A key principle is that the product developer(s) ultimately bear responsibility for translating user and/or patient needs into a set of requirements which can be validated prior to implementation.
This is primarily a design function, however design input requirements encompass inputs from production, quality, key suppliers, and the user. The effect is to reduce any assumptions on the part of the designers.

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Medical Device Design Regulations – Scope and level of detail.
Design input requirements must be comprehensive and generally fall into three categories.
– Functional requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs.
– Performance requirements specify how much or how well the device must perform: speed, strength, response times, accuracy, limits of operation, etc. This includes a quantitative characterization of environment: temperature, humidity, shock, vibration, & EMC. Reliability and safety fit here.
– Interface requirements specify characteristics which are critical to compatibility with external systems; specifically, those characteristics which are mandated by external systems and outside the control of the developers. One interface which is important in every case is the user and/or patient interface.
 

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Assessing inputs for adequacy.
The design input must be reviewed for adequacy. After approval, the design input becomes a controlled document. All future changes will be subject to change control procedures.
Any assessment of design input requirements boils down to a matter of judgement.
The review team should be multidisciplinary and have appropriate authority.
A number of criteria may be used by the review team.
– Design input requirements should be unambiguous.
– Qualitative limits should be expressed with associated tolerance.
– The set of requirements should be self-consistent, no conflicts.
– Environment for use should be properly characterized.
– Cited standards should be reviewed for completeness & relevance.

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Evolution of design inputs.
The initial set of requirements, covering the overall product, are often the most difficult to develop. As the design proceeds, the early stage output becomes input for subsequent stages. Information becomes more extensive and detailed.
Design changes to correct one problem may create new problems. Change control becomes crucial.
From a design control perspective, the number of requirement changes is less important than the thoroughness of the change control process.

 

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References sources:
 

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EU Guidance on Medical Device Regulations   >>>