Richard Tully Email and Phone Number
Eighteen years ago I started at a Notified Body as a fish out of water. With over fifteen years of my life in design and development, and than a decade in regulatory and quality medical device compliance, I am an engineer in a legal world. I like to think that my background, and my love of problem solving, makes me a highly effective partner for all your medical device compliance needs.With engineering always having had the precision that the law lacked, I preferred to design and develop things. I now apply engineering solutions to medical device compliance.Whether it is a tool for demonstrating appropriate Post-Market Surveillance, or a method for making clinical evaluation reports easy to update, engineering the correct solution is a skill. Will the sledgehammer approach of applying resources, both financial and human, be the most effective, or is there space for a more elegant, engineered solution? I get genuine satisfaction from solving regulatory issues, whether it be conducting a Gap Analysis or putting together a Technical File. Aside from my love of design, engineering and mathematics, I am passionate about teaching, something which has threaded its way throughout my entire career. I like to believe that, when I leave a client, the job is completed to their satisfaction and they possess the skill set to independently deal with any similar issues. The aim is to show you how to solve the problems. When I’m not consulting on medical device compliance, I’m working on my own design projects, and my boat.
Compliant Medical Devices Ltd
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DirectorCompliant Medical Devices Ltd Feb 2020 - PresentUnited Kingdom -
Head Of TrainingScarlet Apr 2023 - PresentAmsterdam, North Holland, Netherlands -
Head Of Certification And TrainingScarlet Aug 2021 - Mar 2023Amsterdam, North Holland, Netherlands -
Training DirectorThe Academy Centre Jan 2022 - PresentRiyadh, Saudi ArabiaTraining to Saudi Medical Device Regulations & other global medical device regulations. -
DirectorMeddev Solutions Ltd May 2017 - Jan 2020Provided consultancy for medical device manufacturers in the UK, USA, Europe and the Middle East. This included: • Conducting gap analyses on technical files and quality systems.• Devising new tools for implementation of MDR requirements.• Writing technical files, clinical evaluations and quality procedures.• Bespoke/targeted teaching specific to client requirements.Conducted 31 notified body technical audits on behalf of the notified body UL and attended and taught at their annual conference in 2018.Conducted 15 technical files, and 20 clinical evaluation audits on behalf of the Saudi Food and Drug Authority to the new Saudi regulations and provided over 70 days of teaching to SFDA technical experts on how to implement them.Wrote and delivered courses on the MDR, the IVDR, the Saudi regulations, risk and clinical evaluation. -
Scheme Manager & Technical ExpertBsi Jan 2011 - Apr 2017Milton Keynes, England, United KingdomTechnical specialist active devices for CE marking and Technical Manager of the EMEA Assessor Delivery Team. Conducted more than 100 technical file reviews, over 100 unannounced audits and over 100 ISO 13485 audits.Lectured on ISO standards and Medical Devices Directive. Lectured on the upcoming MDR in several forums. IRCA registered trainer for ISO13485 Courses. Lead auditor for ISO 13485 & ISO 9001 QMS and CE / Medical Device Directive.Actively involved with the Notified Body Software Committee. Sat on the ISO Standards Committee for anaesthesia (Ch121) -
Development EngineerDiamedica Uk Ltd Jun 2005 - Oct 2010Devon, England, United KingdomDesign and build of the Glostavent® Anaesthesia Systems.Employed a wide range of engineering disciplines including electronics, pneumatics, mechanical, software and embedded processors. Lectured globally and wrote peer reviewed papers for academic journals.
Richard Tully Skills
Richard Tully Education Details
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Microelectronic Systems Design
Frequently Asked Questions about Richard Tully
What company does Richard Tully work for?
Richard Tully works for Compliant Medical Devices Ltd
What is Richard Tully's role at the current company?
Richard Tully's current role is Make your medical device fully compliant in a competitive market..
What schools did Richard Tully attend?
Richard Tully attended Brunel University London.
What skills is Richard Tully known for?
Richard Tully has skills like Auditing, Quality Management, Quality System Compliance, Public Speaking, Iso 14971, Mdr, Teaching, Regulatory Documentation, Ivdr, Regulatory Affairs, Biocompatibility, Medical Devices.
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Richard Tully
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1avamae.co.uk
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