Medical Devices & Healthcare

During COVID 19 pandemic, there was a sudden increase in PPE demand globally. To meet this demand, many manufacturers flocked up with Biocompatibility testing requirements. It was pretty challenging to accommodate all products, considering the timeline required by regulatory authorities. It isn't easy to reduce the timeline of animal studies, but our team of experienced experts always found a solution.

We had the challenge to accommodate all projects and maintain our quality at the same time. A team of experts sat together, found the solution, and discussed with our labs and partner labs to define a strategy for accommodating all client products for testing and reduce the maximum possible time.

We were successful in our approach and able to complete all projects in time. All our reports were submitted to various regulatory authorities and accepted without any concerns. We extended our support to all our customers to clarify queries received from the FDA and other regulatory authorities and continued supporting until the product got registered and kept.

All medical devices are being tested for their Biocompatibility to ensure the safety of devices to the end-users. Biocompatibility testing is done using the ISO 10993 series of standards. The standard provides a robust approach to assessing multiple endpoints using small to large laboratory animals. However, it requires many small to large animals.

There are a lot of discussions happening globally to reduce the use of animals in testing, many new alternative methods are being developed. All animal testing requires a massive number of animals, and it takes months to complete testing and is also quite expensive.

We at TÜV SÜD adopted a different approach for our clients to waive off many animal tests. We educated our customers to adopt a new testing strategy using chemical information and doing Toxicological Risk Assessments. Many customers benefit from this approach; we were able to shorten the duration of all required testing and managed to save on cost. By having a quick turnaround time, customers now can reduce overall certification time concerning Biocompatibility.

As the COVID-19 pandemic continues, the need for more intensive care beds has led to the construction of emergency field hospitals. In Bergamo, Italy, an entire hospital was built in ten days, including the essential distribution network of medical gases (carbon dioxide, nitrogen, oxygen, etc.), built and supplied by Air Liquide Sanità Service.

Air Liquide Sanità Service asked our Italian colleagues at TÜV SÜD pH Laboratories to verify and certify the quality of the gases before the new hospital was opened. Even though this wasn’t a conventional hospital and the testing would be a new challenge, time was of the essence. We needed to get the tests done quickly.

To ensure the safety of the medical gas system, our experts from the TÜV SÜD Italy subsidiary checked for impurities in the medical gas according to the requirements stipulated in the European Pharmacopoeia. The testing was completed with a mobile “Quality Gas” lab system accredited according to ISO / IEC 17025. To ensure that the hospital was operational in the quickest time, TÜV SÜD engineers completed all necessary testing and issued the final test report within 24 hours – a record time.

The speed of our response helped ensure the Bergamo field hospital was completed on schedule, paving the way for the rapid deployment of essential medical services in the hard-hit Lombardy region.

Worldwide, only 2% of human waste is disposed of safely. The rest of the world either uses systems that do not treat waste sufficiently (or at all), or lacks access to any toilet facility altogether. While many people fall into the last category, still more use systems that do not provide any type of treatment for the resulting waste.

To bring safe sanitation to 2.3 billion people worldwide, we have partnered with the Bill and Melinda Gates Foundation on several projects to support the 'Reinvent the Toilet' challenge. To succeed in changing the world of sanitation and meeting UN Sustainable Development Goal 6, innovators need to show potential users and investors clear, verified evidence that their technologies meet the communities’ needs. This verification comes from applying international standards for non-sewered sanitation systems (ISO 30500 and ISO 31800).

In collaboration with global stakeholders, TÜV SÜD led the technical development of ISO 30500 and ISO 31800 and now provides unique expertise in helping sanitation innovators ensure their technologies are safe, efficient, effective, and market-ready.