Have thoughts about ISO 13485? Share your feedback!
In follow up to ISO/TC 210 plenary discussions in December 2022 regarding preparatory work on items for revision of ISO 13485:2016, an ISO/TC 210 ad-hoc group has developed a survey for the medical device community about the standard.
The intent of this survey is to gather stakeholder feedback on the existing use of the standard for regulatory purposes. With the current regulatory environment for medical devices, ISO/TC 210/WG 1 needs to gauge stakeholder needs and determine the benefits or negative impacts of a possible revision. In addition, ISO/TC 210/WG 1 needs to understand the stakeholder experience and evaluate any proposed revisions against global regulatory models. If a revision is deemed necessary, the survey data will help guide ISO/TC 210/WG 1 in the creation of new design specifications.
We kindly request that interested parties provide feedback to assist ISO/TC 210/WG 1 with obtaining a holistic view of the use and needs for ISO 13485 stakeholders. The survey can be accessed at https://www.surveymonkey.com/r/6HM26L2 through 31 December 2023.