Clinical laboratories are constantly challenged by an increasingly complex regulatory environment. The FDA has now issued draft guidance on the regulation of Laboratory Developed Tests (LDTs), while previous guidance has also indicated concerns over use of research use only (RUO) products in clinical labs. Unclear over the regulation of their LDT‘s in future, laboratory businesses are facing the unknown.
The European clinical industry also faces a looming transition with new legislation due to replace the current IVD directive 98/79/EC.
This proposes changes in the scope of IVD, classification, conformity assessment and clinical evidence requirements. In Asia, the Chinese FDA has seen major regulation changes under a new leadership with ongoing uncertainty over interpretation.
The majority of the global diagnostics market is anticipating a regulatory transition leaving diagnostic business leaders with concerns over how to mitigate risk, get ahead of the regulation and STAY AHEAD!
In such uncertain times, choosing the right business partners is vital to minimizing risk, staying competitive and having confidence in your compliance.
Tecan provides products and services that are compliant with clinical regulations around the world, with a globally distributed QA/RA organization to ensure an understanding of local needs.
This is why over 80% of the top 30 diagnostic companies place their trust with Tecan.
The same expertise that is available to our IVD partners are built into our Tecan products to support your lab of today and the future.