All About MedTech Blog

The 4 Most Common Mistakes in the Risk Acceptance Matrix

In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was...

Vietnam – a Sourcing Country for the Medical Device Industry?

The strategic decision of where to source materials is becoming increasingly difficult. The trade war between the U.S. and China, the...

Operational Qualification (OQ)

The fun part of medical device process validation! Great, you finished the installation qualification (IQ) and now want to start with the...

Installation Qualification (IQ)

Ticking-off as a necessary evil or to build a strong foundation? Do you think Installation Qualification (IQ) is the least important part...

Medical Device Manufacturing: Are you familiar with Process Validation?

Yeah, sure, it's IQ, OQ, and PQ! What's really behind these acronyms that everyone believes to know! Does your customer suddenly want you...