MD101 Consulting

France

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MD101 Consulting is a specialized French consultancy based in Aubagne that supports medical device companies and health-tech innovators through all stages of regulatory compliance, design control, and global market access. The company relies on a dedicated core team alongside an extensive network of senior industry specialists.

MD101 provides strategic and operational regulatory consulting, focusing heavily on EU Medical Device Regulation (MDR 2017/745), IVDR (2017/746), and US FDA submission pathways (including 510(k), De Novo, and PMA). The firm assists clients in building robust technical documentation, structuring Quality Management Systems compliant with ISO 13485 and 21 CFR Part 820, and ensuring compliance from early design phases through to post-market surveillance.

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MD101 provides comprehensive regulatory, quality assurance, and compliance services tailored to medical device manufacturers:

Design-Level Compliance & Standards Integration: Guidance on implementing standards early in product development, including IEC 60601-1 (medical electrical equipment safety), IEC 62304 (medical software life cycle), ISO 14971 (risk management), and IEC 62366-1 (usability engineering).
CE Marking Support: Preparation, auditing, and remediation of Technical Documentation according to EU MDR 2017/745 and IVDR 2017/746 requirements, including General Safety and Performance Requirements (GSPR) matrices.
FDA Submissions & US Market Access: Gap analyses, regulatory strategy planning, pre-submission (Q-Sub) meetings, and complete 510(k), De Novo, and PMA dossier drafting and submission management.
Quality Management Systems (QMS): Implementation, alignment, and internal auditing under ISO 13485:2016, MDSAP, and FDA Quality System Regulation (21 CFR Part 820 / QMSR).
Digital Health & Cybersecurity: Regulatory roadmaps and compliance validation for Software as a Medical Device (SaMD), artificial intelligence, machine learning, and cybersecurity standards.

MD101 Consulting

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