NAGL MedTech™ employs a proprietary, innovative approach to commercializing medical-device technology in the information-based regulatory environment.
Through fully-integrated, comprehensive life cycle management and proven quality management systems NAGL MedTech™ ELEVATOR® business process will accelerate the development of your idea, vastly mitigate your development risks, and elevate the chances of your commercial success.
How It Works
The ELEVATOR® is an iterative, dynamic process, requiring input from each workgroup involved in the development process. An emphasis is placed on the sharing and evaluation of information throughout the product/project lifecycle.
Process and quality management systems (QMS) are critical more than ever to ensure that development activities are effectively conducted in this cross-functional environment. Why? Proper documentation in various forms now accounts for well more than 50% of the development of a medical device.
QMS, therefore, forms the backbone of successful development and a significant part of the development budget
Client Value
NAGL MedTech™ has the passionate expertise, professional experience, and proven process to deliver unsurpassed medical device product development services – from concept to commercialization or any required stage in between – that minimize risk and optimize the opportunity for financial return. We do this by engaging our device industry experts, who are driven by an entrepreneurial spirit, maintain specific product category expertise, stay ahead of ever-evolving clinical practices, and follow proven quality systems to ensure device development success.
Capital
Investment Costs Minimized
Quality System
Investment Costs Minimized
Human Resource
Investment Costs Minimized
Unique Client Benefits
The ELEVATOR® Approach provides an array of unique benefits to your business incubation including:
- NO LEARNING CURVE – NAGL MedTech™ is an expert in the Medical Device field and latest regulatory requirements with a proven track record
- NO MISSING DESIGN HISTORY FILE – NAGL MedTech™ provides a proven, ISO-certified QMS that ensures appropriate documentation for regulatory submissions
- NO MISALIGNED ACTIVITIES – NAGL MedTech™ provides a single point-of-contact who manages and addresses all project needs and has expertise within the required medical specialty
- NO FRAGMENTED CONTRACTS – NAGL MedTech™ provides a complete service agreement that covers the life of your program, and allows desired flexibility throughout its term
- NO CONFUSING REGULATORY OWNERSHIP – NAGL MedTech™ allows the client to be the ‘spec developer’ and ‘manufacturer’ throughout the entire development process
- NO HIDDEN IP COST – NAGL MedTech™ makes available ownership of the newly created IP to the client as part of the service fee
- NO TRANSFER COST – NAGL MedTech™ allows the product to be fully developed within the company’s own quality system, eliminating the need for future transfer and facilitating scale-up at a new manufacturing location
