JALEX Medical offers a one-stop shop when it comes to Class I & Class II product development & regulatory services. Our team of biomedical engineers, regulatory & quality management specialists all work under one roof to provide your organization with a streamlined & client centered approach to commercialization. We are dedicated to organizations with big ideas but who are short on resources to bring their innovation to market.
Design & Development - Concept Generation and 2D/3D CAD - Medical Device Design per FDA regulations - Creation of Prototypes and Production Components - Verification & Validation
Regulatory - Regulatory Path Assistance & Product Classifications (Class I, II) - 510(k) Submissions - Predicate Device Research - Device/Instrument Registration & Listing - UDI Support
Quality Systems - Quality Management System Development and Implementation per 21 CFR 820 - ISO 13485, MDR, and Canadian Directive - Company Representative during external audits by Regulatory and Third Party Auditors - FDA remediation assistance for 483 observations, warning letters, and consent decrees
Product Categories
Biomaterials
- Bone Graft Delivery Device
Business to Business
- Business to Business
- Customized Testing Solutions
- Materials Supplier
- Mechanical Testing
Consulting Services
- Surgery Center Management/Development
Fusion
- Anterior Cervical Discectomy and Fusion (ACDF)
- Fixation
- Lumbar
- Spine Fusion
Hand Instruments
- Bone Graft Delivery Device
- Bone Probes
- Broaches / Cutters / Taps
- Caspar Cervical Distractor
- Caspar Cervical Retractor
- Compressors / Pliers
- Custom Handles
- Depth Gauges
- Distractors
- Drivers/Screw drivers
- Equipment Covers / Sanitation devices
- Guides / Sets
- Mallets
- Minimally Invasive Equipment
- Pedicle Access Needle
- Rod Benders / Grippers / Pushers / Rockers
- Surgical Drills
- Surgical Microscopes
Implants
- Allografts
- Biomaterials
- Bone Screws
- Cervical Plates
- Disc
- Expandable Interbody Implants
- Hooks
- Interbody Cages
- Interbody Spacers
- Lengthening Components
- Lumbar Plate System
- Pedicle Screws
- Rods
- Stackable Cage Systems
- Staples
- Stents
- Vertebral Body Replacement Systems
Manufacturing
- Additive Manufacturing Services
- Advanced Coatings & Components
- Casting
- Component Parts
- Contract Manufacturers
- Custom Machined Parts
- Design
- Forging
- Implant Manufacturing
- Packaging/Sterilization
Minimally Invasive Surgery
- Endoscopic Instruments
Practice Management
- Consulting Services
Surgery Equipment / Accessories
- Guide Wire
- Hand Tools / Surgical Instruments
- Minimally Invasive Surgery Instruments
- Retractors
- Suction
- Surgical Microscopes