ConceptDesign & DevelopmentVerification and ValidationRegulatoryQMSProduct Launch
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.
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.
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.
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.
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.
Given our experience with bringing medical devices to market, we can offer you informed recommendations about manufacturers, sterilization, and packaging. Our team will assist in writing a customized standard operating procedures and document controls, as well as develop, implement and train for compliance with the FDA Quality System Regulation (QSR) and ISO 13485.
At JALEX we understand the importance of getting your medical devices to market on time, which is why we offer a Project Rescue service. It’s a professional second opinion to the get your project back on track. The JALEX team can review the status of your project and provide solutions to the problems delaying your path to commercialization success.