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

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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ECM (Ente Certificazione Macchine)

ECM (Ente Certificazione Macchine) is accredited by Accredia for the certification of Quality Management Systems to EN ISO 13485:2016 and is also a Notified Body (#1282) designated for the EU Medical Device Directive 93/42/EEC (MDD). ECM supports companies in the complex transition process by performing all the services required for the issuance of certification.

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