JALEX Medical, LLC
Mason Makulinski has a strong background in engineering, particularly in the medical device design and development industry. With experience in Quality Management System, Regulatory Path Assistance, and Manufacturing Engineering, Mason has honed their skills through various co-op positions and their Master of Engineering degree in Mechanical Engineering from the University of Cincinnati. Mason is currently working at JALEX Medical, LLC as a Project Engineer, showcasing their expertise in 2D/3D CAD, FDA regulations, and ISO standards. Mason's dedication to the field is evident through their commitment to learning and growing within the industry.
JALEX Medical, LLC
JALEX Medical is a privately held design, engineering, and product development firm headquartered in Westlake, just west of Cleveland, Ohio. Our highly experienced team has helped hundreds of clients bring innovations to market since 2012. With an emphasis on Class I and Class II devices, JALEX offers unrivaled support and expertise in bringing your idea from Concept to Commercialization. Additionally, our team provides a la carte professional support and expertise throughout design, verification, validation, regulatory, and QMS development phases. Every member of JALEX’s medical device consulting team specializes in his or her department but has thorough cross training in all aspects of the medical device development process. As a result, the team brings tremendous value to our clients by providing all the services you need under one roof. Services include: - Medical Device Design - Regulatory Affairs - Quality Management Systems - Project Management - Project Rescue Areas of Expertise: - Cardiology - Dental - ENT - Gastroenterology - General Surgery - Neurological - Ophthalmology - Oral and Maxillofacial - Orthopedics - Pain Management - Pediatrics - Podiatry - Plastic Surgery - Pulmonology - Radiology - Spine - Upper and lower extremity - Urology - Vascular