Regulatory & Quality Consulting Services

MJ Medica provides senior regulatory affairs and quality support across medical devices, IVD, SaMD, AI-enabled healthcare technologies and pharmaceuticals.

Services range from regulatory strategy and Technical Documentation through QMS implementation and remediation, clinical and performance evidence, market access and post-market compliance.

Two engineers working on a medical device prototype at a wooden table with technical drawings. One holds the device and uses a screwdriver, while the other looks on. A large monitor in the background displays an exploded view of the device's internal components.

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.

A medical professional analyzing brain and lung scan images on dual computer monitors in an office with large windows and cityscape view.

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, software V&V, traceability and lifecycle documentation.

Two engineers in white lab coats and hair nets examining a tablet in a manufacturing facility with conveyor belts and computer screens.

Quality Management Systems

ISO 13485 QMS implementation and remediation, design controls, CAPA, internal and supplier audits, inspection readiness, eQMS support and quality-system improvement.

Additional Regulatory & Compliance Support

FDA & Global Regulatory

FDA regulatory support including 510(k), PMA, Q-Sub/meeting packages, regulatory strategy, submission documentation and support for global market access.

Clinical, Performance & Post-Market

Clinical and performance evaluation, CER/PER support, PMS, PMCF/PMPF, complaint and vigilance processes, trend analysis and post-market reporting.

UK Responsible Person & UK Market Access

UK Responsible Person services, UK MDR 2002 compliance, MHRA registration, manufacturer due diligence, labelling review, vigilance and ongoing UK market support.

Need Regulatory or Quality Support?

Whether you need focused support for a specific regulatory challenge or additional senior expertise for a larger programme, MJ Medica can provide flexible support tailored to your requirements.

  • Technical Documentation, regulatory submissions, QMS remediation, clinical and performance evidence, PMS and other clearly defined deliverables.

  • Senior support for complex remediation, audit or inspection readiness, regulatory gaps and quality-system improvement.

  • Short-term, fractional or longer-term regulatory and quality support aligned with your organisation, workload and priorities.

DISCUSS YOUR PROJECT

Discuss Your Regulatory or Quality Project

Tell us about your project, regulatory challenge or quality-system needs. MJ Medica can provide flexible senior-level support for defined projects, remediation programmes or ongoing consultancy engagements.