Quality & Regulatory
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
Custom Solutions for Everything Vital
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
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 – Degania, Biometrix and Arthesys 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 – Degania Silicone/ Biometrix/ Arthesys
- FDA 510(K) Clearance – Degania Silicone/ Arthesvs
- QMS part in accordance with the EMDR 2017/745
- QMD technical documentation is progressing toward compliance with MDR(EU) 2017/45
- For enquiries about the product registration (CE mark, FDA, etc.) please contact your local representative.
Sustainability & Environmental
QMD aspires to minimize its impact on the environment and maximize the effective use of resources.
The QMD Centers of Excellence (Arthesys, Degania Silicone Ltd, Degania Medical Products Pvt, Ltd) 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.