Robert Beck

Robert is an expert in software and I.T. regulatory services bringing a unique background to the consulting team. He has administered and understands software validation, Part 11 compliance, QSR and ISO standards as they apply to software, and FDA guidance documents on clinical computerized systems. Robert wrote software sections for a number of successful products, including firmware, software-only, and multiple equipment interfaces. He has worked on more than 50 medical device clinical trials.

Matt Kennedy

Matthew is an experienced Quality Systems Manager with over 18 years of expertise in Regulatory, Manufacturing, Design, and of course, Quality. Matt takes the time to focus on a company's agreed upon goal and then takes the proper course of action to achieve the desired result. He believes in developing systems by integrating the regulatory requirements in the planning process, which in turn streamlines the work for your company.

Linda LaVine

Linda is an experienced Quality System Specialist in the medical device industry. She provides companies with expertise in developing, implementing, and maintaining quality assurance systems for a variety of devices and levels of company sophistication. Her experience allows her to support easier maintenance and greater compliance with regulatory requirements. Linda is a proven problem-solver who works collaboratively with management and cross-functional teams.

Todd Osborn

Todd has 20 years of experience in Quality Assurance Engineering and continues to exceed performance expectations for the companies with which he consults. He strives to contribute to the success of an organization by improving productivity and profitability by developing, implementing, and monitoring the quality system and processes to ensure full compliance with the U.S., Canadian, European, and International standards.

John Pulley

John has over 24 years of manufacturing experience with eleven of those years in the medical device industry. Not only has John worked as a Quality Assurance Engineer for medical device organizations, but he has also been trained to audit companies based on a number of ISO/ANSI/AAMI/EN standards. Because of his extensive knowledge in this area, John was recruited as a Medical Audit Team Leader and he provides training seminars to companies and individuals.

Marilyn Siewart

Marilyn has over 35 years of quality assurance experience in the medical device industry and additional expertise with the IVD Directive. She offers leadership and professional insight for companies during any point on their path to bringing their product to market. She has served as a Director of Quality Assurance at a vast array of medical device companies. Marilyn is a RABQSA Certified Lead Auditor with many more certifications and credentials under her belt.

Melinda Swanson

Since 1995, Melinda has worked in a variety of leadership roles within regulatory and clinical services. Her job titles have included, Clinical Director, Director of Clinical and Regulatory Affairs, Vice President of Clinical and Regulatory Affairs, and Senior Director. Melinda takes a hands-on approach to helping companies meet strategic and business objectives domestically and internationally.

Lora Tjomstol

Lora is a consulting professional with over 11 years of experience in process and product engineering, commercialization, project management, regulatory and operations/quality management. She has a proven track record of successful medical device product launches for cardiovascular, neurovascular, and orthopedic markets. Lora's long list of skills includes CE Marking, FDA submissions, Quality Assurance Audits, Risk Management, and program management for product commercialization.

Jennifer Royston (JR) Tonjum

JR has more than 20 years experience in Quality Systems and Manufacturing Operations. She has experience with medical devices and pharmaceutical products offering clients a broad knowledge base when it comes to current Good Manufacturing and Laboratory Practices and quality system standards. Her background includes implementation of Quality Management Systems, development of Quality Documents, internal and supplier audits, nonconformance systems, and training. JR is a detail-oriented professional who believes in adding value to whatever project she is given.

Alan Vanhouten

Alan is an experienced Senior Project Engineer with expertise in all areas related to bringing new single-use medical devices to market and into high volume production. Beyond the broad view of project management, Alan can assist with the details such as identifying specifications of mechanical components, analysis of technical drawings, and development of a system interface that conforms to standards, customer requirements, and system architecture requirements.