Our Team

Education and Professional Membership

• PhD Organic Chemistry
• MSc Analytical Chemistry and Instrumentation
• BSc Chemistry and Physical Education and Sports Science

Skills Summary

• EU MDR and ISO 13485 gap assessments, strategy planning and implementation.
• Preparation of regulatory strategies to support submissions in EU, UK and US.
• Development and remediation of technical documentation.
• Authoring of technical documentation, e.g., usability, PMS, risk, classification, applicable       standards, GSPRs, specifications, compliance statements and declarations.
• Authoring of QMS procedures, e.g., usability, clinical evaluation, UK registrations and  UKRP.
• Authoring of guidance documents for the EU and UK markets.
•  Registration of devices on the MHRA DORS.

Profile

Results-driven and committed, James has over 18 years of industry experience in Quality, Regulatory, Design Assurance and Device Development. James’ field of expertise includes  the EU MDD, EU MDR and UK MDR.

James has worked for several device manufacturers, in areas such as ophthalmic, perinatal, neurological, rehabilitation and implants for cranio-maxillofacial surgery and the extremities.

In addition, James has a solid working knowledge of the EU IVDD, EU IVDR  and FDA QSR and has been actively involved in all phases of the device development process, from concepts to product launch.