Regulatory Affairs & Quality Consulting
Medical Devices | IVD | SaMD & AI | Pharmaceuticals
Senior regulatory and quality consultancy supporting manufacturers across product development, regulatory approval, quality systems and post-market compliance.
Regulatory & Quality Consulting Services
EU MDR & IVDR
Technical Documentation creation and remediation, regulatory strategy, classification, GSPR compliance, ISO 14971 risk management, clinical and performance evaluation, and Notified Body support.
SaMD, AI & Digital Health
Regulatory and quality support for standalone SaMD and AI-enabled medical devices, including IEC 62304, IEC 82304-1, ISO 14971, cybersecurity and software V&V
Quality Management Systems
ISO 13485 QMS implementation and remediation, design controls, CAPA, audits, supplier quality and inspection readiness.”
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Senior Regulatory Expertise. Practical Delivery.
Led by Michael Murphy PhD, MJ Medica Consulting brings more than 20 years of regulatory affairs and quality experience across medical devices, IVD, SaMD, AI-enabled healthcare and pharmaceuticals. Support ranges from focused regulatory and quality projects to complex remediation programmes, with an emphasis on practical solutions, clear deliverables and regulatory readiness.
Discuss Your Project
Tell us briefly about your regulatory or quality requirements. MJ Medica will respond promptly to discuss your project, priorities and how we can support you.