ISO13485 - 7.3.1 Design and development planning

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7.3.1 Design and development planning

The organization shall establish documented procedures for design and development. The organization shall plan and control the design and development of product.

During the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification, validation and design transfer activities (see Note) that are appropriate at each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be documented, and updated as appropriate, as the design and development progresses (see 4.2.3).

NOTE Design Transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.

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