Our Wide Range of Medical Design Services
With a deep specialization in Class I and II devices, JALEX Medical bridges the gap between innovative ideas and regulatory success. Our multidisciplinary team of engineers and specialists works under one roof to ensure every design is manufacturable, every submission is compliant, and every project is on track.
From Concept to Market and Every Phase in Between
JALEX Medical allows all facets of your product development, regulatory, and quality needs to be conveniently managed in one central location, expediting your idea to commercialization. We also offer individual services based on your product requirements. JALEX Medical will tailor our services to meet your needs.
Medical Device Design
JALEX Medical offers full-service design and engineering to bring your medical device from initial concept through production. Our expert engineers ensure your device is approvable, manufacturable, and regulatory-compliant from day one.
Regulatory Affairs Consulting
Navigate the FDA regulatory process with confidence through JALEX Medical's decades of experience and proven track record. Our regulatory experts have successfully guided hundreds of medical devices to market clearance.
Quality Management Systems
JALEX Medical designs, implements, and maintains robust quality management systems tailored to your specific needs and compliant with FDA QSR 21 CFR 820 and ISO 13485. Our QMS specialists provide audit support, risk management, and comprehensive training to keep you in compliance.
Project Management
JALEX Medical provides full oversight of your entire medical device development process with transparent communication and cross-functional expertise. Since 2012, our team of engineers has exclusively focused on bringing medical devices to market efficiently and correctly the first time.
Project Rescue
JALEX Medical's Project Rescue service provides expert analysis and proven solutions to get your stalled medical device project back on track toward successful commercialization. Our cross-functional team identifies problems and delivers concrete solutions to overcome regulatory issues, delays, and development roadblocks.
Our Process
01
Concept
Innovative medical devices start from an idea created by real-world experience. JALEX Medical has the expertise to capture your idea and start the process of bringing it to life.
02
Design and Development
Once the concept is established, we begin the process of 3D CAD model generation, finalizing materials and manufacturing requirements, and creating a prototype to evaluate the fit and function.
03
Verification and Validation
Verification and Validation are critical points in product development that ensure your device performs as intended. The JALEX Medical team will facilitate these development activities including risk assessment, sterilization and packaging, mechanical testing, and process validation.
04
Regulatory Affairs
Our regulatory specialists will compile all the necessary documentation that ensures your device will be safe and effective for human use and in compliance with US and International regulations. This documentation includes 510(k) submissions, Technical Files for CE Mark, and the required registration and listing of your device with appropriate agencies.
05
Quality Management Systems
A robust quality management system defines, controls, and improves the processes that revolve around the manufacturing and use of your medical device. Our quality experts can help you design, manage, and maintain a quality management system that will instill confidence in your team and keep you in compliance.
06
Product Launch
Given our experience with bringing medical devices to market, we can offer you informed recommendations about manufacturers, sterilization, and packaging. We can manage or help you navigate all the activities necessary for commercialization, so you can have a successful and timely product launch.
Need a Custom Solution for Your Medical Device Project?
Every medical device project is unique. Whether you need full-service support from concept to commercialization or specialized assistance in specific areas, JALEX Medical will create a customized package tailored to your project’s specific requirements and timeline. Let us design the right combination of services to get your device to market efficiently and successfully.
