GOOD HOSPITAL PRACTICE

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Updated on 4 February 2025

5.2.02 Design planning (development inputs)

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Goal and purpose

Determination of the requirements that are essential for the respective product and service types.

Inputs must be appropriate, complete and unambiguous for the development purposes. Contradictory development inputs must be eliminated.

Requirements for the documentation of development inputs.

Application

Description of the process

Risks

Resources

Material

Time required

Documentation

Responsibility and qualification

Notes and comments

Applicable documents

Validation documents

DIN EN ISO 9001:2015 and DIN EN 15224:2017 8.3;