As you may be aware from our previous blog post, the European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be […]

For their March issue, Medical Product Outsourcing Magazine interviewed Ryan Harper, PBL's Business Development Director, regarding recent medical device testing changes and developments.  The article discusses current industry trends, additions […]

The FDA recently launched a new pilot program called Quality in 510(k) or Quik that allows manufacturers of moderate risk medical devices to use the eSubmitter software program to submit […]

The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be enforced starting May 25th, 2020.  This new regulation repeals the […]

Gene therapy has broken out of its chains. In 2017 alone, Kymriah (Novartis), Luxturna (Spark), and Yescarta (Kite Pharma/Gilead) received FDA approval.  The number of small gene therapy companies is […]

Pacific BioLabs has purchased and validated a QuickPlex SQ 120 MSD instrument and we are now accepting requests for MSD studies.  The instrument will be used for immunogenicity testing, biomarker […]

The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear dynamic range. In highly complex matrices, the TripleTOF 5600 provides high-resolution of low- abundance analytes which is just […]

In the spring of 2018, PBL purchased a SciEx 5600 TripleTOF mass spectrometer. That instrument is now fully validated and ready to use for regulated studies. Please see PBL's blog […]

Pacific BioLabs have been performing reusable device cleaning validations for over a decade.  Traditionally, PBL has performed cleaning validations by testing three devices over three different cleaning cycles giving a […]

On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet the premarket notification requirements under section 510(k) of the Federal […]