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Medical Device Manufacturers

The rapid development of our competence center for medical devices has continued to grow. With its excellent service, DQS Inc. continues to support customers anywhere in the world. This growth is also a result of increasing international requirements. Therefore, we will support you while entering new worldwide markets for manufacturers of medical devices.

Increasing internationalization is challenging for us and our customers but also a great opportunity. Below are the services that we already offer to our customers worldwide.

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MDSAP

Meet multiple requirements with a single audit.

ISO 9001

Quality management More than one million certified companies in the world take advantage of the notable ISO 9001 standard as a tool for managing their organization.

ISO 14001

Environmental Management System (EMS) This refers to the management of an organization’s environmental programs. These programs are comprehensive, systematic, planned and documented. An EMS includes the organizational structure, planning and resources for developing, implementing and maintaining ...

ISO 13485

Medical Devices ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices in the United States, Japan, Canada, and the European Union.

ESD S20.20

Electrostatic Discharge ESD is more than the “static shock” we experience in our everyday lives. As micro-circuit architecture becomes smaller and more complex, ESD sensitive devices become more susceptible to damage resulting from an electrostatic event.

Gap Assessments

The Preliminary/Gap Evaluation is a limited sample assessment of your quality system based on the respective ISO standard and is offered at any time.

ISO 15378

Primary packaging materials for medicinal products Pharmaceutical companies need to ensure that their own supplier audits fulfill relevant legal requirements. This is why when selecting a supplier of packaging materials, particular attention needs to be paid to their ability to fulfill current GMP ...

ISO 22301

Business Continuity Management A Business Continuity Management System (BCMS) includes disaster management, emergency management and other business continuity programs.

ISO 27001

Information Security Management Systems ISO 27001:2013 is the only auditable International Standard for Information Security Management Systems (ISMS).

ISO 50001

Energy Management Systems The rising costs of energy, the need to handle resources responsibly, and the increase of global trade all require new and concrete approaches to energy usage.

Non-certification & Supplier Audits

Audits for your specific needs DQS Inc. Non-Certification process audits are multi-faceted; however, they have one focus, which is to provide value that is measurable for companies and organizations who wish to enhance their performance beyond the pressure of a certification or a complete assessmen...

OHSAS 18001/ISO 45001

Occupational Health and Safety  This standard assists organizations in managing and controlling their health and safety risks and improving their Occupational Health & Safety performance.
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