Quality and Regulatory Consulting

Carolyn Guthrie started Helix Medical in 2021, and has spent 20 years in various quality and regulatory roles within the medical device industry.

Carolyn Guthrie (MS Cell Biology and Genetics, MS Regulatory, RAC) has extensive experience in regulatory submissions in the United States and European Union, as well as implementation and management of all aspects of medical device quality management. Carolyn specializes in global strategy to ensure regulatory objectives meet commercialization and other business objectives. Her experience spans various technologies from orthopedic (spinal, foot and ankle, craniomaxillofacial), wound care, and software as a medical device. Submissions include successful breakthrough designations, 30+ 510(k)s, INDs, all types of Q-subs, and CE marking under both MDD and MDR. Carolyn regularly speaks on various topics in the quality and regulatory space, with a passion for breaking down complex topics into executable activities.

Katelyn Jessup has spent nearly 10 years in the medical device industry in quality and regulatory roles. The latter half of these years she has been a consultant providing regulatory and quality support to many customers, from start-ups to large corporations, in different stages of their device journey.  Her work has included a wide range of QA/RA activities such as implementing and executing quality management system processes, training staff, auditing, evaluating and implementing changes in regulations and requirements, writing regulatory assessments, and supporting with regulatory submissions.

Katelyn’s main medical device experience includes working with clients in orthopedics, dental, and instrumentation, along with collaboration in technologies including SaMD, IVDs, and wound care.  She holds a BS Nutrition Science and Biology, minor Chemistry, and an MBA in Business Management.  She is Lead Auditor certified in ISO 13485:2016 and 21 CFR 820 and recently received a certification from RAPS in EU Regulations.