Medical Device Development Professionals
The AAHS Annual Meeting
January 8-11th
Fort Lauderdale, Florida


JALEX Medical is a Cleveland, Ohio medical device development company. Our philosophy is simple, exceed customer expectations regardless the project size. Period.

If you are curious about getting outsourced development help for your team, then let's talk.
Business Director- JALEX Medical
Attending AAHS January 9-10th
216.307.6299
Concept • Design & Development • Verification & Validation • Regulatory • QMS • Product Launch 
AREA OF EXPERTISE

Orthopaedics
Neuro/Spine
Urology
General Surgery
Ophthalmology
Dental
Mobile Health Applications
ENGINEERING

Concept Generation
2D/3D CAD Modeling
Design for Manufacturability
Engineering Analysis – FEA
Material Selection
Prototyping
Risk Assessment
Sterilization & Packaging
Mechanical Testing
Commercialization
REGULATORY/ QA

Regulatory Pathway – US and International
510(k) Submissions
Post-launch regulatory support
QMS development
Compliance auditing
21 CFR 820
ISO 13485, ISO 9001
UDI (Unique Device Identification)