All About MedTech Blog

6 Reasons Why Your Technical Understanding is Essential to Validate Processes in MedTech

Process validation ensures that manufacturing processes reliably produce products that meet predetermined specifications and quality...

Performance Qualification (PQ) – Run 3 batches and ready, right?

Great, you finished the Operational Qualification (OQ), found your process window, and now must show the consistency of your process. 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...