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Track Your QSR Shipment

Online tracking available for Twinsburg-based accounts only. For other QSR locations, select below for more information.

Your QSR Account Number can be found on your invoices and packing slips in the format of "1234-56"

For order tracking in Jasper, GA, contact your QSR customer service representative:

Vikki Stanger
[email protected]
706-692-8626

For order tracking in Jasper, GA, contact your QSR customer service representative:

Vikki Stanger
[email protected]
706-692-8626

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Quality & Regulatory Services

Capable, Scalable and Compliant

A Partner You Can Trust

  • Outstanding commitment to excellence
  • Systematic continuous improvement and performance
  • Microprocessor-controlled production environments
  • Laser technology for in-line dimensional process control
  • Lean/Six Sigma focus on process capability and efficiency
  • Dedicated cleanrooms and machinery eliminate cross-contamination
  • Steadfast focus on providing products that exceed expectations

Quality Management

QMD weaves quality management into every step of production by:

  • Maintaining ISO Certification standards: ISO 13485:2016 and  ISO 9001:2015
  • Compliance in select facilities with 21 CFR part 820
  • Registration of select facilities as a Medical Devices Manufacturer with the FDA
  • Maintaining  ISO Class 7 and Class 8 cleanrooms for molding, extruding, secondary and finishing operations, according to the standard ISO 14644 series
  • Designing and developing devices in accordance with the harmonized standards, including ISO 10993, ISO 11607, ISO 14971, ISO 11135, and ISO 11137 along with state-of-the-art requirement USP 23 Class VI and other guidance

Certifications and Approvals

Regulatory Affairs

QMD products are manufactured to meet regulatory approvals worldwide:

  • Development of regulatory strategies
  • Continuous product regulatory support
  • Global pre-market approval assistance, including:
    • CE: MDD 93/42/EEC
    • FDA 510(K) Clearance
  • QMS part in accordance with the EMDR 2017/745
  • QMD technical documentation is progressing toward compliance with MDR(EU) 2017/45

Sustainability & Environmental

QMD aspires to minimize its impact on the environment and maximize the effective use of resources.

The QMD Centers of Excellence (Saclay, France; Degania Bet, Israel; DMD, India) are ISO 14001 compliant sites dedicated to environmental management and sustainability. As part of their effort to reduce environmental impact, these facilities have put programs into place that track, monitor and improve environmental goals typified by reducing landfill waste generation and overall energy consumption.

How can we help?

Let’s start a conversation about your medical device.

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