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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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checklists and templates

Templates that Facilitate the Use of Clinical Data from IIS in CER and PMCF Reporting

IIS Templates blog - Slide-in cover

Here are 3, free, customizable templates that you can offer to investigators pursuing IIS with your device. These templates are both a reminder and a helpful resource: EU GDPR Consent (privacy policy), Work Instructions for Electronic Data Capture Systems and eForm Designer.

Want more free medical device resources? Click here to access our full library of downloadable content!
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