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

USA

Israel

Degania Bet

ISO 13485: 2016
ISO 14001: 2015

Jerusalem

ISO 13485: 2016

Europe

Slovakia

ISO 13485: 2016 – Biometrix

LR ISO 14001: 2015 – Biometrix

ISO 13485: 2016 – Arthesys

France

ISO 13485: 2016

India

ISO 13485: 2016
ISO 45001: 2018
ISO 14001: 2018

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 Class I
- 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 (Rock Hill, SC; Twinsburg, OH; Sturtevant, WI; 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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