"Alyssa was an invaluable resource for my project. She patiently answered all questions about regulatory requirements and helped brainstorm the most effective ways the project could stay on schedule and satisfy regulations. I found Alyssa to be very knowledgeable, thorough, and thoughtful in all information she provided to the team."
Alyssa Thomas, the principal consultant, has a Bachelor of Science degree in Industrial/Manufacturing Engineering from Oregon State University. Alyssa also has her RAC (Regulatory Affairs Certification) professional credential from the Regulatory Affairs Professional Society. She has completed a multitude of continuing education courses, including passing the ISO 13485 Lead Auditor training exam. Alyssa’s engineering degree enables her to communicate in technical terms that the clients’ product developers understand. Recognizing the engineering perspective, as well as the medical device reviewer’s position, is the advantage Allegiance Regulatory Consulting offers our clients.
The mission of Allegiance Regulatory Consulting is to provide regulatory advice and execute regulatory activities for our clients to enable efficient market access of their products and ensure compliant systems, thereby allowing them to achieve their revenue goals by bringing their products to market quickly.
Allegiance Regulatory Consulting has over 13 years of experience in the medical device industry. Our device experience ranges from orthopedic implants, jet injection systems, an ophthalmic device, to a Bag-Valve-Mask resuscitator. Our experience is with products made from a variety of materials, using different sterilization methods. Understanding the viewpoints of everyone involved in registration and product development enables us to navigate and explain the regulatory maze to help our clients launch their products in the global marketplace. We use our regulatory expertise to find solutions to drive the activities that support our clients’ needs. Experience is not all that matters, it’s what we do with our experience that gets results for our clients, allowing them to sell products globally to meet sales targets.