NAMSA and RAPS are delighted to host the first live edition of the RA QA Café , a podcast about trending medtech regulatory and quality topics.
In this episode, our hosts, Linford Leitch (regulatory consultant) and Richard Granquist (senior quality system onsultant) will sit down with two of NAMSA’s UK-based MDR experts to discuss, among other things:
Although this episode will later be released as an audio podcast, the live event will contain video and plenty of opportunity for audience interaction and Q&A.
Registration Fees
Price: $0 Member | $25 NonMember
Learning Objectives
Understand and apply best practices for writing PSURs and documenting the benefit-risk of your device.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend?
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers:
Linford Leitch
Regulatory Consultant, NAMSA
In 2021, Linford joined NAMSA as a regulatory consultant. He has nine years of experience in the medical device industry with direct regulatory experience with spine, transcatheter heart valves and hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.Linford is one of the two hosts of the recently launched RA QA Café podcast.
Richard Granquist
Senior Quality System Consultant, NAMSA
Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.
Rich started in the medical device industry as a microbiologist focusing on preclinical testing, including packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a quality engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a quality systems consultant. He has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.Rich is one of the two hosts of the recently launched RA QA Café podcast.
Matt Royle
Principal Regulatory Consultant, NAMSA
Matt Royle has 18 years of experience working cross-functionally within both medium-sized and muntinational medical device start-ups, which has allowed him to develop an understanding of the regulatory and quality challenges unique to each.
Matt began his career in 2004 working in research and product development for Corin, a UK-based orthopaedic joint replacement manufacturer, where he focused on implant submissions to the U.S. Food and Drug Administration (FDA) and developing new surgical instrument systems. Matt returned to academia in 2008 to pursue a PhD, sponsored by Corin, in orthopaedic engineering. He then broadened his device knowledge by working for a small spinal bone grafting company, where he was responsible for ensuring ongoing maintenance of CE technical files and design dossiers for CE marking under the EU Medical Device Directive (MDD), as well as compiling 510(k) submissions. In 2013, Matt joined DePuy Synthes as a senior bioengineer, working on a number of hip development projects, before joining LRQA, a UK-based notified body, as a product specialist in orthopaedics and spinal, where he conducted class III design dossier and class IIb/IIa technical file reviews against Directive 93/42/EEC. Matt joined NAMSA in 2019 and has worked with a range of different medical device manufacturers, advising on how to navigate the requirements of the EU Medical Device Regulation (MDR) and create compliant technical documentation.
Paul Risborough
Principal Regulatory Consultant, NAMSA
Paul Risborough, who joined NAMSA in June 2021, has over 25 years of experience in the medical device industry working with many active medical device technologies. Paul began his medical device career as an electronics technician supporting the design and manufacture of syringe pumps. He stayed in the infusion device industry for several years, developing the Alaris range of syringe pumps and large volume pumps as an electronics design engineer, production engineer and an electronics engineering manager. Paul then moved to Integra Neuro Sciences as production engineering manager before moving to ML Electronics as medical project leader. Paul’s regulatory career began when he joined BSI as an active device product specialist in 2011 In 2013, Paul was appointed as part of the BSI active implantable medical device (AIMD) team and in 2015, was promoted to the global head of active implantable medical devices.
