Navigating the medical device development process can present challenges to innovators. From initial concept all the way through commercialization, JALEX Medical provides the highest quality support to get your medical device to market efficiently. In short, our specialists provide the expert knowledge and support you need to succeed.
From Initial Concept to Design & Development
JALEX Medical is uniquely focused on helping innovators bring their medical devices to market. Of course, innovative medical devices start from an idea created by real-world experiences. That said, JALEX’s engineers solely work in the medical device space and have the industry expertise to capture your idea and bring it to life.
After concept development, we move on to medical device design with 2D/3D CAD generation. Next, our engineers source and procure an appropriate functioning prototype to evaluate fit and function. In addition, material needs and manufacturing requirements are established during this stage of development.
Verification, Validation, and Regulatory Support
To ensure your device performs as intended, JALEX provides assistance throughout the verification and validation process. Accordingly, this phase of product development includes risk assessment, mechanical testing, and validation (reprocessing, sterilization, cleaning, packaging) testing.
Our regulatory specialists compile all necessary documentation to put you in compliance with US and international regulations and provide full regulatory affairs support. Therefore, this documentation includes 510(k) submissions, technical files for CE Mark, and the required registration and listing of your device with appropriate agencies.
JALEX Medical Device Development Process Leads to Commercialization
Of course, the focus throughout the entire process is achieving clearance and product launch. Given our experience with bringing medical devices to market, we offer informed recommendations and project management support to engage with the right manufacturing, sterilization, and packaging partners.
Additionally, JALEX provides Quality Management Systems support, writing customized standard operating procedures and document controls. To that end, our team can help you develop, implement, and train for compliance with the FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485.
Has your current project hit a wall? JALEX offers a Project Rescue service. In short, this is a professional second opinion to get your project back on track. Our specialists can review your project and provide solutions to the problems delaying your path to commercialization.
Your Trusted Partner is Here
Wherever you are in the medical device development process, JALEX has you covered.
Contact our team today and find the support and expertise that makes JALEX a trusted source for so many in the medical device industry.