Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles on biocompatibility topics.

He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods, and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

Edwin serves as Managing Director and Principal Consultant with over 20 years of experience in the Life Sciences and Medical Devices/IVD industry. He has proven expertise in regulatory affairs, clinical operations, and quality assurance, and has worked extensively with early-stage and start-up companies to bring products to market.

Edwin’s experience includes collaborating with regulatory agencies such as Notified Bodies, MHRA, US FDA, Health Canada, and Japanese PMDA. He has successfully developed and executed regulatory strategies, securing multiple US FDA 510(k) clearances, IDE and PMA approvals, as well as CE Mark Technical File and Design Dossier approvals.

His current clients include the Scottish National Blood Transfusion Service, Sure Retractors, Current Health, Abbott, Neurovalens, Bioretec, Axis3d, Kuros Biosciences, Vascular Flow Technologies, Abingdon, and Brightwake. Edwin has experience with all classes of devices, from active to implantable, including custom devices, electronics, and software/artificial intelligence.

Recently, he served on the UK Trade and Investment Healthcare Advisory Group, providing consultancy to the UK government on healthcare issues and export strategies.

In addition to his consultancy work, Edwin lectures on medical device regulations at the University of Strathclyde and Glasgow University. He also serves as a coach for the EU Commission’s Horizon 2020 Funding Programme, providing quality and regulatory advice to companies.

Christopher Phillips is an experienced leader with 20 years of experience in Medical Device Regulatory Affairs, Quality Systems, and Clinical Affairs.

Christopher has helped bring innovative medical devices to market in the USA, Europe, Canada, Australia, Brazil and other global markets; and has built and maintained ISO 13485- and 21 CFR 820-compliant Quality Management Systems.

Christopher has played key roles in designing, developing, and launching novel software- and AI/ML-based medical devices, digital health software products, implantable medical devices, and disposable medical devices, including developing nonclinical and in vivo studies, designing and supporting clinical trials, and managing clinical evaluations.

Christopher possesses extensive knowledge and understanding of requirements of the FDA, European Medical Device Regulation, Canadian Medical Devices Regulation, and other international regulations. Christopher completed a Master of Science degree in Health Sciences focused on Regulatory Affairs and holds RAC and CMDA certifications.

A quality driven Engineer, Aaron has overseen the quality management systems and regulatory affairs for a range of vascular access products. He has 13+ years of experience in the medical device industry, with a background in biomedical engineering and certifications in ISO 13485 auditing and risk management.

Aaron's core competencies include Regulatory strategy, product development, design verification and validation, CE (MDR), FDA and ISO compliance, automation engineering, and robotics. He has led or supported multiple projects involving electrical design, panel build, programming, and SOPs for automated equipment. Aaron is passionate about delivering quality products that meet the needs and expectations of customers and regulator.

Jonathan Carr, JD is the Chief Compliance Officer and a member of the executive management team at ARUP Laboratories in Salt Lake City, Utah.  Jonathan currently oversees the Compliance, Privacy, Risk, and Intellectual Property programs.  

For several years Jonathan also directed the Quality Management team at ARUP, during implementation of ISO 15189.  Prior to joining ARUP in 2012, Jonathan practiced law at a litigation firm in Tampa, Florida for several years. He graduated from Brigham Young University with a degree in Biology before attending Florida State University College of Law.  Jonathan is a member of the Utah State Bar, the US Patent Bar, the Risk and Insurance Management Society, and the Health Care Compliance Association.