Spec Developer ELEVATOR®

Need Help with Developing Your Product?

Explore Our Spec Developer ELEVATOR® Services

The Spec Developer ELEVATOR® at NAGLREITER® is ideal for a client who needs development services for a medical device product. From early-stage concepts, through design controls, the NAGLREITER® team manages every aspect of the project to reach the company’s end goal.

Clients within the Spec Developer ELEVATOR® have access to Systems, Equipment, and Workforce services, and their projects are run within the NAGLREITER® quality system to ensure best-in-class products.

NAGLREITER® uses a tested, four-phase development strategy to help clients bring devices from early-stage concepts, through design controls, and beyond. Design qualifications, clinical validations, and regulatory submission and approval are all processes conducted within the Spec Developer ELEVATOR®.

The following NAGLREITER® Services are available and are tailored to design, develop, test, and completely validate your medical product.

Workforce 

  • World class product development teams consisting of program managers, product development engineers, quality assurance engineers, regulatory/clinical support
  • Product marketing support staff

Systems Access & Use

  • Products will be developed utilizing NAGLREITER’s® proven quality and business systems – in keeping with the latest ISO and FDA guidance and regulations 
  • Product development software packages (i.e., SolidWorks, QT9, FEA Software)

Equipment & Facilities

  • State of the art R&D lab, clinical simulation lab for benchtop validations, 3D printing and prototyping areas, measuring equipment 
  • Packaging and labeling services 
  • Advanced catheter and balloon development equipment 
  • Validated ETO sterile cycle 
  • Calibration and maintenance of equipment
  • Electrospinning equipment

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