Sam Bacon - Associate Consultant

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I have five years’ experience working with numerous medical device clients to develop and implement the following:

• Quality Management Systems (QMS) to ISO 13485:2016 compliance including Class I, IIa, IIb and SaMD
• Technical File Summary Reports to EU MDR 2017/745 and the UK MDR 2002 including Class I, IIa, IIb and Software as a Medical Device (SaMD)
• FDA Submissions for both SaMD and Medical Devices including Traditional 510k, 513g and Enforcement Discretion
• MDSAP Projects, PMS and CER Reports
• Development of supporting documentation for Technical Files such as
• Risk Management Plans / Hazard Identification / FMEAs / Risk Management Final Reports to ISO 14971:2019
• Essential Requirements Evaluations to UK MDR 2002
• GSPR Evaluations to Annex I of EU MDR 2017/745
• Device classification according to both the EU MDR 2017/745 and UK MDR 2002 including SaMD
• Device labelling / artwork including SaMD in compliance with CE and UK CA Marking requirements and ISO 15223:2021
• UDI / EUDAMED Project Management for device registrations required for European market access
• EU Authorised Representative (EU Rep) and UK Responsible Person (UK RP) Services
• NHS Market Access including DTAC, DSPT and DCB0129
• ISO 13485:2016 Certified Internal Auditor
• GAP Analysis and remedial work to ensure technical documentation compliance with relevant international standards
• GAP Analysis and remedial work in relation to Notified Body reports following ISO 13485 and/or ISO 27001 Certification or Surveillance Audits

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Paul Rowden - Senior Consultant

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I'm a global Quality Assurance and Regulatory Affairs specialist with over twenty three years’ experience in the Medical Devices & IVD sectors.

Accredited as an Internationally Certified Principal Auditor, I have been instrumental in Quality Assurance and Regulatory Affairs strategy for large medical device / IVD manufacturers. With an impeccable record, I have successfully guided over 500 clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.

My extensive knowledge within the Regulatory Compliance and Quality Assurance profession has seen me hold key positions as an Internationally Certified Principal and Lead Auditor.

As the Director of European Device Solutions Ltd, we are a professional quality and regulatory affairs consultancy, representing Medical Device businesses and products through the ISO 13485:2016 registration of CE marking, complaint handling and adverse incident report processes.

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Jeff McBride - Associate Software Consultant

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Jeff McBride has over thirty years’ experience in ensuring that automated health care technologies are compliant with all current regulatory requirements.

Widely acknowledged subject quality and regulatory matter expert in mobile health applications. Utilising expertise honed through working with the ‘Clearblue’ brand of female reproductive health medical device products and with Biocartis, has been at the forefront of the proliferation of mobile applications or “apps,” beginning in 2012 with the device “Oncoassist,” the application becoming one of the first “Health Apps,” to be certified as a medical device authorised to affix the “CE” mark to their product. There followed subsequence success with other leading edge mHealth devices, Medopad, Hinge Health, Advanced Ophthalmic Systems, Atlas Biomed, plus many others.

Gaining regulatory recognition for clients Medical Devices from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, the Health Products Regulatory Agency (HPRA) in Ireland and Food and Drug Administration (FDA) in the USA and many other similar regulatory agencies worldwide.

Obtaining International Standards accreditation and certification for clients Medical Devices to ISO13485 and ISO27001.

As a result of his pioneering success in this market almost ten years ago, Jeff has been in ongoing demand from early stage tech entrepreneurs and development agencies including the UK DIT, Enterprise Ireland, and industry representative groups. As one of the principals of European Device Solutions, Jeff’s experience is now available to your company.