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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. .

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NAGL MedTech™ Product Development Process

Phase A – Proof of Concept

Identify the strategic considerations for product development beyond the product itself – clinical, regulatory, reimbursement, production, packaging, etc. – to help create a blueprint for success.

Phase 1 – Definition of Feasibility

Fully defining your product and providing that the design is feasible by passing all product specifications.

Phase 2 – Design and Development

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.

Phase 3 – Validation

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

Equipment Services

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.

System Services

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.

Workforce Services

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.

Past Successes

The team’s level of professionalism, work ethic, knowledge and dedication are extremely high. I’ve enjoyed working with them a great deal and have learned a lot from them. Additionally, we’ve been impressed with the continuing ability of NAGL MedTech™ to pull in additional high-quality people as our needs have expanded.

Darius Kharabi, EMBA Medical General Manager

NAGL MedTech™ has been an important addition to the Safestitch Medical team. Brett is intelligent and experienced in the medical device industry from a regulatory and engineering perspective. He is on task, organized, efficient and perhaps above all has excellent interpersonal skills

Dr. Charles Filipi – Safestitch Co-Founder & CMO

Your achievements at Surefire over the last 10 months have been exemplary, including your leadership and technical guidance to the entire team. I am extremely impressed with the way you led the company to successful submission of 510(k), on time, and with high quality standards.

Jim Chomas – CEO / Founder, Surefire Medical Inc.

I was very satisfied with the level of service from the NAGL MedTech™ team. They integrated very well with both the Fremont and Cork team members. Without their support, completing various aspects of the project would not have been possible within the tight timeline and scope of the project.

Sean McFerran, Stryker Neurovascular Program Manager

NAGL MedTech™ provided clear direction and communication to the project. Team was able to resolve several key design challenges in a timely and efficient manner. This included redesign of key device components to allow successful completion of the Phase A design process.

Dr. Andrew Cragg, Intersect Partners

NAGL MedTech™ is very proactive and has really spear-headed this project well. They have wonderful project managers.

Dr. Baharak Moshiree, University of Miami

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.