{"id":4669,"date":"2022-09-16T10:12:28","date_gmt":"2022-09-16T15:12:28","guid":{"rendered":"https:\/\/casusconsulting.com\/?page_id=4669"},"modified":"2023-11-21T07:12:23","modified_gmt":"2023-11-21T13:12:23","slug":"tools-and-templates","status":"publish","type":"page","link":"https:\/\/casusconsulting.com\/tools-and-templates\/","title":{"rendered":"Tools & Templates"},"content":{"rendered":"

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Tools & Templates<\/strong><\/span><\/h2>\n

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\"MDR\/IVDR<\/div><\/a>\n\t <\/div>\n\t
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\n\t MDR\/IVDR Legacy Devices: Significant Change Assessment Tool<\/a>\n\t <\/h3>\n\t
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Our tool helps assess if a device change is non-significant, maintaining legacy status. Or if a change is significant, requiring ...<\/p>\n\t\t\t <\/div>\n\t

October 31, 2023<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"EU<\/div><\/a>\n\t <\/div>\n\t
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\n\t EU Vigilance Requirements<\/a>\n\t <\/h3>\n\t
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MDR\/IVDR\/UKCA vigilance reporting process for medical devices & IVDs in Europe, UK and Switzerland, plus Competent Authority contacts. Free and ...<\/p>\n\t\t\t <\/div>\n\t

March 15, 2023<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"Periodic<\/div><\/a>\n\t <\/div>\n\t
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\n\t Periodic Safety Update Report Template<\/a>\n\t <\/h3>\n\t
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A PSUR is a stand-alone document created as part of a manufacturer\u2019s post-market surveillance system. Find here free templates Casus ...<\/p>\n\t\t\t <\/div>\n\t

December 29, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"European<\/div><\/a>\n\t <\/div>\n\t
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\n\t European Registration Requirements<\/a>\n\t <\/h3>\n\t
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Find out which markets require registration for Class IIa, IIb and III medical devices, self-test and Annex II, List A, ...<\/p>\n\t\t\t <\/div>\n\t

December 19, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"Important<\/div><\/a>\n\t <\/div>\n\t
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\n\t Important Dates: Europe, UK and Switzerland<\/a>\n\t <\/h3>\n\t
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Important Dates \u2013 ALL For the purpose of this page, \u201cEurope\u201d = the EU-27, Iceland, Liechtenstein, Norway, Northern Ireland, and ...<\/p>\n\t\t\t <\/div>\n\t

November 16, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"Declaration<\/div><\/a>\n\t <\/div>\n\t
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\n\t Declarations of Conformity Templates<\/a>\n\t <\/h3>\n\t
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EU and UK Declaration of Conformity templates available for download in word format.<\/p>\n\t\t\t <\/div>\n\t

September 17, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"Language<\/div><\/a>\n\t <\/div>\n\t
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\n\t Language Requirements Tool<\/a>\n\t <\/h3>\n\t
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Free EU MDR\/IVDR Language Translation Tool. Confirm IFU translation requirements for medical devices & IVDs in Europe, UK and Switzerland, ...<\/p>\n\t\t\t <\/div>\n\t

May 5, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>
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\"EU<\/div><\/a>\n\t <\/div>\n\t
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\n\t EU MDR Classification Tool<\/a>\n\t <\/h3>\n\t
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Try our EU MDR 2017\/745 classification tool (interactive flowchart). Download a free PDF of your results: EU device class & ...<\/p>\n\t\t\t <\/div>\n\t

April 14, 2022<\/div><\/div>\n\t <\/div>\n\t\t\t\t<\/div>\n <\/article>\n <\/div><\/div>\n\t\t\t\t
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