Our Approach

NAGLREITER® 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 NAGLREITER® 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

NAGLREITER® is the only Medical Device Development Organization (MDDO) that 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 minimizes risk and optimizes the opportunity for financial return. We do this by engaging our device industry experts, who are driven by an entrepreneurial spirit, who maintain specific product category expertise, who stay ahead of ever-evolving clinical practices, and who 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 – NAGLREITER® is an expert in the Medical Device field and latest regulatory requirements with a proven track record
  • NO MISSING DESIGN HISTORY FILE – NAGLREITER® provides a proven, ISO-certified QMS that ensures appropriate documentation for regulatory submissions
  • NO MISALIGNED ACTIVITIES – NAGLREITER® provides a single point-of-contact who manages and addresses all project needs and has expertise within the required medical specialty
  • NO FRAGMENTED CONTRACTS – NAGLREITER® provides a complete service agreement that covers the life of your program, and allows desired flexibility throughout its term
  • NO CONFUSING REGULATORY OWNERSHIP – NAGLREITER® allows the client to be the ‘spec developer’ and ‘manufacturer’ throughout the entire development process
  • NO HIDDEN IP COST – NAGLREITER® makes available ownership of the newly created IP to the client as part of the service fee
  • NO TRANSFER COST – NAGLREITER® 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

We invite you to learn more about NAGLREITER® and what makes us truly unique.