BRINGING YOUR LIFESAVING MEDICAL DEVICE TO LIFE
NAGL MedTech’s™ Spec Development solutions are backed by full regulatory compliance with the FDA, up-to-date ISO 13485 Certifications, and a validated ETO sterile cycle. We specialize in catheter-based products, small electronic devices, orthopedic kitting, cleanroom assembly, and more. With 60+ employees and over 17,000 square feet of medical device development and manufacturing space, NAGL MedTech™ is the perfect partner for MedTech companies both large and small. .
NAGL MedTech™ Product Development Process
Identify the strategic considerations for product development beyond the product itself – clinical, regulatory, reimbursement, production, packaging, etc. – to help create a blueprint for success.
Fully defining your product and providing that the design is feasible by passing all product specifications.
Implement product design and development while continually refining and verifying product design details to optimize success. For Class II products, NAGL MedTech™ will prepare and submit 510k documentation and data to the FDA.
Ensure the final design meets intended needs along with all safety, regulatory, and technical requirements. In addition, certify that scale-up manufacturing processes are clearly defined and qualified to consistently meet established production quality specifications.
NAGL MedTech™ Drives Your Development
With NAGL MedTech™ running your product development, you’re adding a level of project accountability and process expertise that will increase product quality and consistency resulting in faster market launch at a lower cost.
NAGL MedTech™ takes complete control of managing everything needed for your development project, allowing the client to breath easy that things will be handled in line with all regulations. All clients are assigned a dedicated project manager who will work with you to develop a timeline of deliverables by project phase and take full responsibility for keeping everything on time and on budget.
Support From Concept to Commercialization
NAGL MedTech™ offers state-of-the-art design technologies including product prototyping, a full in-house machine shop, 3-D printing capabilities, a dedicated R&D lab space, and more. All work is done at our integrated facility which include ISO Class 8 Compliant Cleanrooms, QA testing labs, inspection, packaging, labeling, storage and more.
NAGL MedTech™ utilizes extensive business and quality management systems (FDA and ISO 13485:2016) to ensure document quality, core development process tracking, ongoing client communication, asset review and disposition, information security, and IT systems.
NAGL MedTech™ provides access to an in-house team of experts in product development, regulatory, quality management, and more, so that from design to production, you can be sure that the people on your project carry the expertise required to complete your project efficiently and effectively.
Develop With Confidence
From concept to commercialization, or any stage in between, our goal at NAGL MedTech™ is to minimize your financial risk, optimize your financial return, and, ultimately, ensure development of a safe and effective product that advances the standard of care.
Start Your Project Today
From phase A all the way through commercialization, NAGL MedTech™ can handle it all – proof of concept, definition and feasibility, development, and validation – at a level of quality and confidence that will exceed your expectations.