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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Ultimate Guide to Comparing Quality Management System Solutions

ECM (Ente Certificazione Macchine)

Recent Posts

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Post-Market Surveillance for Medical Devices & IVDs: Requirements & Proactive Data Collection

Data Management and Reporting in FDA-Regulated Clinical Trials

Be the first to know the latest news in the MedTech industry.

Focus on the Work That Matters Most.

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

ECM (Ente Certificazione Macchine)

Recent Posts

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Post-Market Surveillance for Medical Devices & IVDs: Requirements & Proactive Data Collection

Data Management and Reporting in FDA-Regulated Clinical Trials

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Be the first to know the latest news in the MedTech industry.

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