How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]
The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]
In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]
The coronavirus has had a massive impact on the medical device industry. As a c [...]
Regulators such as FDA, European Commission (EC), ISO 13485 require a product c [...]
Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]
Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quali [...]
Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise qualit [...]
Experience shows that out-of-the-box configured software only works for business [...]
With more modern-day compliance enforcement, life science manufacturers and dist [...]
The Life Sciences industry has always been fast-paced and competitive. Changes a [...]