AJ Medical Manufacturing
US-based contract manufacturer of medical devices and components offering vertically integrated design-to-commercialization services. Maintains an ISO 13485 quality management system and FDA registration, operates an ISO 14644-1 Class 8 cleanroom, and provides engineering, regulatory, prototyping, verification, and high-volume manufacturing and packaging services for Class I–III medical devices.
Industries
Nr. of Employees
small (1-50)
AJ Medical Manufacturing
16710 HEDGECROFT DR SUITE 100, HOUSTON, TX 77060, USA
Products
Medical Device Manufacturing
Contract manufacturing of medical devices and components, providing production services to medical device companies.
Medical Device Manufacturing
Contract manufacturing of medical devices and components, providing production services to medical device companies.
Services
Complete contract manufacturing including manual and automated assembly, electromechanical assembly, welding and bonding, high-volume consumable assembly, and custom pack/kitting.
Design control, prototyping, validation, and design-to-commercialization planning for Class I–III medical devices, including CE marking support.
Evaluation of 510(k) requirements, gap analysis, predicate review, preparation and submission of 510(k) applications, and FDA correspondence on behalf of clients.
Digital prototyping, additive manufacturing, mechanical and thermal FEA, CFD, drop/impact testing, and shape optimization to support product development.
Pilot and production tool design with injection molding production supported by an in-house machine shop.
Complete contract manufacturing including manual and automated assembly, electromechanical assembly, welding and bonding, high-volume consumable assembly, and custom pack/kitting.
Design control, prototyping, validation, and design-to-commercialization planning for Class I–III medical devices, including CE marking support.
Evaluation of 510(k) requirements, gap analysis, predicate review, preparation and submission of 510(k) applications, and FDA correspondence on behalf of clients.
Digital prototyping, additive manufacturing, mechanical and thermal FEA, CFD, drop/impact testing, and shape optimization to support product development.
Pilot and production tool design with injection molding production supported by an in-house machine shop.
Expertise Areas
- Contract medical device manufacturing
- Design for manufacturing (DFM)
- Regulatory submission support (510(k))
- Injection molding and tooling
Key Technologies
- Injection molding
- Additive manufacturing (3D printing)
- Ultrasonic welding
- Laser welding
News & Updates
Certificate confirming the company's quality management system for contract manufacturing, assembly, and packaging of non-sterile products in compliance with ISO 13485:2016.
Facility certified as meeting ISO 14644-1:2015 Class 8 cleanroom requirements.
Facility listed as registered with the U.S. Food and Drug Administration for medical device manufacturing.
Certificate confirming the company's quality management system for contract manufacturing, assembly, and packaging of non-sterile products in compliance with ISO 13485:2016.
Facility certified as meeting ISO 14644-1:2015 Class 8 cleanroom requirements.
Facility listed as registered with the U.S. Food and Drug Administration for medical device manufacturing.