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
Industry
Medical Equipment Manufacturing, Research & Development, Research, Engineering & Consulting, Regulatory Compliance Services, ADA Compliance Consulting Services, Compliance Services, Services, Program Management Services, Air Management Services
HQ Location
27865 Clemens Rd.
Westlake, Ohio (OH) 44145, US
Keywords
Medical DevicesRegulatory AffairsQuality Management Systems510(k) submissionsUnique Device IdentificatioBiomedical EngineeringFDAOrthopedicsProduct DevelopmentProject Management