Which records need to be signed with a hand-written signature (or electronic equivalent)?

In ISO 13485:2016 there are no strict requirements regarding the type of signature. In the requirement 4.2.4 Control of documents is stated following documents need to be review and approve documents for adequacy prior to issue; that each document needs to be reviewed, update as necessary and re-approve documents; ensure that the current revision status of and changes to documents are identified; ensure that relevant versions of applicable documents are available at points of use; ensure that documents remain legible and readily identifiable.

In requirement 4.2.5 Control of records is stated that each record shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

So it is up to your organization how this will be solved.

For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following link:

• Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/