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Regulatory Affairs


REGULATORY STRATEGY

• Is my software a medical device (MD)?
• Definition of the normative and regulatory context
• Definition of the MD class

CE MARKING

Preparation & Update of the Technical File in accordance with the MDR 2017/745 Regulation

INTERNATIONAL SUBMISSION

Regulatory Registration and Submission Internationally (USA, Canada, …)

Quality Assurance


IMPLEMENTATION AND IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM (QMS)

ISO 13485

COMPLIANCE OF THE QMS WITH REGULATORY REQUIREMENTS

MDR 2017/745 – MDSAP

REGULATORY AND STANDARDIZATION MONITORING


INTERNAL AUDIT
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