E-ssentials MedDev Blog

Regulatory updates for the medical device industry

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:

 

  • usability evaluation
  • testing of functional safety of active medical devices in accordance with IEC 60601-1
  • testing of electromagnetic compatibility in accordance with the EMC Directive (Directive 2014/30/EU)
  • testing of electrical and electronic devices in accordance with the RoHS Directive (EU Directive 2002/95/EG)
  • software testing
  • environmental testing
  • biocompatibility testing in accordance with GLP (Good Laboratory Practice)
  • microbiological testing
  • physical, biological and chemical testing
  • validation of sterilization processes

 

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.

For more information on the areas of expertise and services provided by TÜV SÜD Product Service, visit TÜV SÜD’s website.

 

Or contact us and discuss your needs directly with one of our medical device specialists.