Standard Search Report Template (Medical Device Standard)

Identifying applicable standards (and in some cases also regulations and directives) and recording them in one document is useful to prevent omitting important standards.

1. If you are developing a brand-new product, search for applicable standards early in the planning phase. The standards will be part of the scope.

2. It is recommended to maintain this list every half year to identify changes/additions to the list.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with the current project.

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Should you want to learn more about using the template or design and development in general, it is covered in two of our public blended training courses: Design Control for Medical Devices – Practitioner Training and Project Management for Product Development of Medical Devices– Practitioner Training. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.