About Us
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Richard Young
Managing Director Prior to founding ABC, Richard had more than 20 years experience in senior Quality Assurance and Regulatory Affairs roles in a diverse range of Medical Device and In Vitro Diagnostic (IVD) companies. Having travelled the world honing his expertise and gaining an extensive range of industry contacts, Richard now feels he can independently offer a truly innovative range of services - all designed with you in mind. His goal is to provide you with exactly what you need, quickly and effectively. Connect via Linkedin |
Associate Consultants
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Leeanne Baker
Quality and Regulatory Leeanne has extensive experience of Regulatory & Quality projects from companies who have dealt with a range of products including Neurology, Diagnostics, Orthopaedics and Contraceptive Devices. She has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada. |
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Rebecca Kemble, PhD
Clinical Research Rebecca is an experienced senior Clinical Research Professional who has worked in a variety of areas such as Orthopaedics, Oncology and CVD. She has international experience in Post-Market Clinical and Regulatory Studies, including Project Management, study design, data analysis and writing of reports. |
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George Mudie
Design, Quality & Validation George is very experienced in risk-based product life-cycle compliance; whether it be evolving products, creating test plans and protocols, performing a validation, constructing technical files or auditing a supplier. He can help from initial concept through to full project management, installing quality systems and product delivery. He has worked across a variety of areas such as Orthopaedics, Oncology and CVD. |
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James Shearn
Regulatory Affairs James has 25 years of experience working within the Medical Devices and IVD industry. His in depth knowledge has developed through roles with multi-nationals in the drug infusion, cardiac and diabetes care sectors. He has extensive implementational experience with the EU Medical Devices Regulations, MDR/IVDR and strong skillsets in International Regulatory Strategy and Regulatory Intelligence. |
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Catriona Underwood
Quality & Regulatory Catriona is one of our MDR experts. She had experience in designing, developing and manufacturing devices before moving over to Quality Assurance and Regulatory Affairs. She's particularly interested in MDR and MDSAP requirements, and stays up to date with new regulatory regulations. |
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George Boukouris, PhD
Sales & Marketing George has worked in the healthcare industry for over 15 years, with experience in the Pharmaceutical, Medical Device and Manufacturing sectors. He specialises in all aspects of developing sales and marketing strategy, with experience of European, Asian, Australian and South American markets. |
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David Cousens
Graphic Design David is a talented graphic artist who works with ABC to develop, simplify and illustrate instructions for use (IFU) documents to improve product usability. |
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Steve Hall
Software Testing & Validation An IT Professional since 1996, Steve has a range of skills but specialises in software testing, particularly test automation. He can review and plan testing for all levels of medical device software. He has experience of COTS tools such as QTP and TestComplete, and Open Source tools like Selenium. He can script in various languages - VBScript, Python and PowerShell etc. |
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Jason Howes
Quality and Regulatory Jason is a Medical Device Regulatory Affairs and Quality Systems specialist, with a wide range of capabilities to support lifecycle activities from design validations through to multi-market approvals. He has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada. |
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James Castelow
Quality and Regulatory James has extensive experience of Regulatory & Quality projects from companies who have dealt with a diverse range of products and services. He has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada. |
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Michael Walsh
Project Management & Marketing - Ireland Michael has over 20 years experience in the Medical Device industry, in the USA and Ireland, overseeing projects as diverse as building a manufacturing plant to managing international product distribution channels. He is a former board member of The Irish Medical and Surgical Trade Association, sits on the Commercial Advisory Board to i360 Medical and is a member of the Irish Medical Devices Association. |
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Alex Slizza
Quality & Regulatory - USA Alex has 20 years experience of third-party auditing in Medical Device and Biotech environments. As well as acting as the US representative for companies planning to enter the US market, he also offers a range of Quality and Auditing services to help organisations withstand scrutiny from the FDA and other Government agencies. |
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Christian Anders
Product Development & Project Management Christian is a highly successful project manager with a diverse range of experience in the Medical Devices and Diagnostics sectors. He has consistently delivered new product development/improvement projects and critical recovery projects - all within scope, on-time and on-budget. |
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Steve Patterson
Design & Validation Steve is very experienced in developing new medical devices, installing quality systems and improving processes. Whether it's evolving a product, performing a validation, auditing a supplier or training staff, Steve prides himself on delivering a solution quickly and effectively. He can help from initial concept through to full project management and product delivery. |
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Neil Garner
Project Management & Quality Assurance Neil has over 35 years experience in the global medical devices industry, gained through varying senior management roles. He started as an orthopaedic product engineer, progressing to Senior VP at Symmetry Medical Europe. He now works as a consultant and also chairs the Sheffield City Region LEP Health Technologies Sector Group. |
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Marcus Gould
In Vitro Diagnostics Specialist Marcus is very experienced in submitting and obtaining CE Marking approval for a range of medical devices and IVD class and types, for both pre- and post-market activities. He also has experience with regard to post-market interactions with Notified Bodies and Competent Authorities, as well as dealing with pre-submission, IDE and 510(k) submissions for the US FDA. |
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Paul Clark
Australasian Representative Paul has over 20 years experience in the Medical Devices industry, working in various capacities (inc. Regulatory, Quality and Clinical) for companies in Australia, USA and Canada. He now specialises in the ANZ market. His expertise covers a wide range of technologies, including renal, cardiovascular, opthalmic, drug delivery, gastrointestinal, active implantables and monitoring devices. |
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Ted Takada
Regulatory Support & Project Management - Asia Ted has over 25 years experience in the pharmaceutical industry, consulting in all aspects of strategic business development across Asia - especially in Japan. His broad knowledge and skills can help with the complexities of regulatory and cultural issues for anyone planning on entering the Asian market. |
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Gavin Beath
Audit Specialist - Asia Based in Japan, Gavin has been performing GMP and QMS supplier audits around East Asia for over 10 years in the chemical, food, pharmaceutical and medical device industries. He is certified by the American Society for Quality (ASQ) as a Biomedical Auditor (CBA), and the International Register of Certified Auditors (IRCA) as a Lead Auditor for Quality Management Systems (QMS) |
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ABC is a member of Medilink West Midlands
Click here to see their June 2015 article about us! |
