Below we would like to show you which advantages you have as a customer or auditor with us as your partner, what we may offer you and who we are overall.
Advantages of being a customer:
- More than 25 years as an independent and competent conformity assessment partner
- Proven expertise in the area of medical devices
- More than 200 auditors and technical experts worldwide with about 1,200 customers
- Experience exceeding 10,000 audits
- Transparency with quotes and achievement performance
- Swift processing and distinctive customer orientation
- Our customer service representatives provide for service continuity
- Proven standard procedures for the optimization of the business performance
- Comprehensive and sound expert’s knowledge for the practical implementation in order to achieve tangible competitive advantages in an increasingly complex market
- Commitment to the highest degree of integrity and the highest level of professional skills for assessments and evaluations
- Highest standards of impartiality regarding certification activities
Advantages of being an auditor:
- Auditor training program organized by our experienced DQS MED Auditor Management and accompanied by mentors
- Opportunity to expand your training across several regulations / standards offered by DQS MED
- Expansion of knowledge due to collaboration and exchanges with experienced DQS auditors (from specialists to quality managers)
- Opportunity to work with wide range of DQS MED customers (from small business to global market leaders)
- Expansion of knowledge through DQS MED workshops, trainings and seminars
- Option for self-employment
- Possibility to travel for national and internal audits
- Experiencing different auditing styles, in form from annual surveillance to unannounced audits or technical file reviews
- Flexible mobile working opportunities due to expanded IT landscape, providing online upload possibilities for training certificates or audit documents
- Competitive compensation scheme
What else we can do for you
Certifications and accreditations on the basis of
- ISO 9001: Standard applied and recognized worldwide to ensure the quality of processes and results in order to improve the competitive factor. Relevant for: Every enterprise. The standard enjoys a high level of recognition in healthcare and related social systems.
- ISO 13485: Process-oriented, industry-specific standard based on ISO 9001 with further requirements concerning safety and traceability. Relevant for: Manufacturers, distributors and service providers in the medical devices sector.
- ISO 15378: is based on ISO 9001 and additionally comprises all GMP (Good Manufacturing Practices) requirements relevant for primary packaging materials. Relevant for: Manufacturers of primary packaging materials for drugs and manufacturers with a special focus on hygiene.
- MDSAP: Receive evidence of regulatory compliance of your QMS with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Relevant for: Manufacturer of medical devices with international focus interested in minimizing disruptions due to multiple regulatory audits or inspections.
- Medical Devices Regulation (EU) 2017/745: for the European Council: Prerequisite for placing medical devices on the market in the European Union. Relevant for: Manufacturers of higher than class I medical devices.
- Technical Cooperation program (TCP lll) - Taiwan: of the Taiwan Food and Drug Administration (TFDA) was initiated in order to reduce duplicate audits and thus to reduce time and costs by the exchange of Taiwanese GMP and ISO 13485 audit reports. Relevant for: Manufacturers of medical devices seeking access to Taiwanese market who must demonstrate compliance with R.O.C. regulatory requirements.
Since we keep expanding our product portfolio, come and visit our website, if you are interested in any other standards.
DQS Medizinprodukte GmbH - About Us
- Independent and competent management partner for companies of all sizes and in all industries
- In 1995, established as the DQS center of excellence for medical devices and designated as a notified body (identification number 0297) approved by the ZLG
- Founded in 2008 as a wholly owned subsidiary of DQS Holding GmbH
- Operating in the areas of medical devices approvals and certification of management system in the health care markets:
- MDSAP recognized auditing organization since 2018
- MDR (EU) 2017/745 notified body since 2020
- Currently serving more than 1,200 customers with more than 220 auditors and experts located all over the world
- More than 80 offices in over 60 countries, we are working with approx. 25,000 customers currently representing approximately 65,000 certified sites in over 130 countries in almost all industries
- Worldwide, approximately 3,000 employees, including around 2,500 auditors and experts
- Is today one of the world´s largest system certification bodies
- Other German subsidiaries of DQS Holding GmbH, headquartered in Frankfurt am Main:
- DQS GmbH
- DQS BiT
- DQS CFS