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.
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 ...
Medical Device Directive
The Medical Device Directive 93/42/EEC (MDD) was established on June 14, 1998 and later amended on September 5, 2007. This directive became mandatory on March 21, 2010. The intent of the directive was to harmonize the regulatory requirements for medical devices with the European Union.
ISO 13485
Medical Devices
ISO 13485:2016 is an internationally recognized quality standard that encompasses specific requirements of an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer as well as regulatory requirements. ISO 13485 is ...
MDSAP
Meet multiple requirements with a single audit.
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.
ISO 27001
Information Security Management Systems
ISO 27001:2013 is the only auditable International Standard for Information Security Management Systems (ISMS).
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 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.
