€49,97

This template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Directive 93/42/EEC.

The template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Directive 93/42/EEC. For devices that also need to comply with other directives, these should all be indicated on the Declaration. For questions, please contact us at info@instrktiv.com. See also our template that complies with […]

€49,97

€49,97

This template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Regulation (EU)2017/745.

The template contains the content of the Declaration of Conformity (DoC) for Medical Devices according to Regulation (EU)2017/745. For devices that also need to comply with other directives, these should all be indicated on the Declaration. For questions, please contact us at info@instrktiv.com.

€49,97

EU User Manual Template Medical Devices

For Medical Devices

EU Medical

€299

The user manual template is an MS Word template, that contains all mandatory elements to create your own user guide. You can use the template to create a manual that complies with the CE marking requirements, the Medical Device Regulation/Medical Device Directive, the EN 820179 standard for User Instructions and the ANSI Z535.6 for Safety Messages.

Essential instruction manual template for all manufacturers, importers and distributors that trade medical devices within the European Union to pass customs with no delays, be able to sell your medical devices within the EU and decrease liability. You want to import, trade and/or sell your medical devices on the European […]

€299

Consultancy 30 Minutes

30 mins Consultancy Time

EU Medical

€75

Schedule a 30-minute call with one of our experts to answer your questions related to CE marking or other compliance matters.

Schedule a 30-minute call with one of our experts to answer your questions related to CE marking or other compliance matters. For scheduling appointments, please contact us at info@instrktiv.com.

€75

Consultancy 60 Minutes

60 mins Consultancy Time

EU Medical

€150

Schedule a 60-minute call with one of our experts to answer your questions related to CE marking or other compliance matters.

Schedule a 60-minute call with one of our experts to answer your questions related to CE marking or other compliance matters. For scheduling appointments, please contact us at info@instrktiv.com.

€150

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