TÜV SÜD Product Service is the global partner for the industry in the field of testing, certification and approval of medical devices, consumer goods, and industrial products. TÜV SÜD Product Service employs almost 5000 staff, around 500 of whom are experts in medical devices, and is thus the largest Notified Body for the industry in the world.
Our highly specialized experts support manufacturers of active implantable medical devices, non-active medical devices, and in vitro diagnostic devices, supplying a comprehensive array of services that span the entire product life cycle:
DEVELOPMENT AND PRODUCTION
Testing and assessment of medical devices:
TÜV SÜD Product Service supplies laboratory product testing and examinations from a global network of accredited testing laboratories, both during the development phase and within the scope of approval. The company focuses on testing the products’ performance, safety and conformity with the regulations in place on the target markets:
For more information, visit TÜV SÜD’s corporate website.
Risk management in accordance with EN ISO 14971
The specialists at TÜV SÜD Product Service are familiar with every aspect of risk management in accordance with EN ISO 14971. Their expertise can help manufacturers detect risks at an early stage, and identify areas of potential improvement in usability or functional safety. This can enhance the safety and performance of medical devices, and smooth their progress to market launch.
Review of design dossiers and assessment of clinical evaluation reports
The medical device experts at TÜV SÜD Product Service have comprehensive expertise concerning approval procedures at their fingertips, and can provide manufacturers with guidance about aligning their clinical data and design dossiers to their target markets from the early stages of development. Supplying these pre- certification services to manufacturers, TÜV SÜD Product Service helps them avoid unnecessary effort and delay in reworking design dossiers or clinical documentation. And if time is at a premium, TÜV SÜD Product Service offers flexible Expedited Design Dossier Services with significantly shorter assessment time.
MARKET APPROVAL AND MARKETING
Medical device certification and approval:
TÜV SÜD Product Service is the world’s largest Notified Body for medical devices, and is at home on all global markets. Its medical device specialists are located throughout the world and are thoroughly familiar with the various approval requirements in place in different countries. As active members of numerous official bodies and professional organizations, they are always up to date with regulatory developments and changes.
These highly skilled experts conduct all necessary conformity testing, and issue type examination certificates for medical devices in accordance with all EU regulations, and CE marks for medical devices destined for the EU market. As a Nationally Recognized Testing Laboratory (NRTL), TÜV SÜD Product Service is also accredited to perform type testing, and issue 510(k) certificates for the USA and Canada. In addition, TÜV SÜD Product Service is authorized to issue globally recognized CB test reports and certificates.
Quality management and quality control
Manufacturers must provide evidence of a certified quality management system for all major markets. Certification from TÜV SÜD Product Service furnishes proof that your production operations fulfill the requirements of the applicable international standards, e.g. EN ISO 13485.