Senior Regulatory Expertise.

Practical Delivery.

MJ Medica Consulting Ltd provides senior-level regulatory affairs and quality consultancy to medical devices, IVD, SaMD, AI-enabled healthcare and pharmaceutical organisations.

Led by Michael Murphy PhD, MJ Medica brings over 20 years of experience across regulatory affairs, quality management, product development and post-market compliance. Experience spans EU MDR and IVDR, UK MDR, FDA requirements, ISO 13485 quality systems, ISO 14971 risk management, SaMD and AI-enabled medical devices, clinical and performance evaluation, and global regulatory submissions.

The focus is practical delivery — helping organisations solve complex regulatory and quality challenges, remediate Technical Documentation and quality systems, prepare for regulatory scrutiny, and bring compliant healthcare products to market. Support can be provided for defined projects, remediation programmes or longer-term consultancy engagements.

Engineers discussing medical device design with technical drawings, a laptop displaying a 3D model of a device, and various tools and documents on a wooden table.

Senior Expertise. Flexible Support

MJ Medica Consulting Ltd provides independent senior-level regulatory affairs and quality consultancy across medical devices, IVD, SaMD, AI-enabled healthcare and pharmaceuticals.

Led by Michael Murphy PhD, the consultancy draws on more than 20 years of experience supporting organisations across product development, regulatory submissions, quality systems and post-market compliance.

Support can be tailored to the needs of each organisation — from focused Technical Documentation or QMS remediation projects through to longer-term regulatory and quality consultancy.

Engagements can support established manufacturers, start-ups and organisations preparing for market entry, regulatory submissions, audits or Notified Body scrutiny.

Since our inception, we have advanced organizations across sectors by pairing strategic insight with disciplined execution.

Modern office space with a wooden desk, laptop, design sketches, books, and plants near large windows

Why Work With MJ Medica?

Independent senior-level expertise without the complexity of a large consultancy. MJ Medica provides practical, proportionate support tailored to your product, organisation and regulatory objectives.

Discuss Your Regulatory or Quality Project

Tell me briefly about your project, regulatory challenge or quality requirements. I’ll get back to you to discuss the scope, priorities and how MJ Medica can support you.