Medical Device, Toxicology
2021 Revisions to ISO 10993
The International Organization of Standardization (ISO) is an independent, non-governmental international organization with a membership of 165 national standards bodies. […]
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Microbiology, Pharmaceuticals
Burkholderia cepacia and the new USP <60>
The United States Pharmacopeia (USP) has published a new general chapter, the USP <60> which will become official on December […]
Analytical Chemistry, Medical Device, Microbiology, Toxicology
FTIR – A Helpful Tool to Determine Chemical Composition
Fourier-transformed infrared spectroscopy, also known as FTIR, is a method of analyzing both organic and inorganic materials, and can provide […]
Analytical Chemistry, Medical Device, Microbiology, Toxicology
Updates to EU’s New Medical Device Regulation (MDR)
As you may be aware from our previous blog post, the European Union published the new Medical Device Regulation (MDR) […]
Medical Device
The Quick Program speeds up 510(k) Reviews
The FDA recently launched a new pilot program called Quality in 510(k) or Quik that allows manufacturers of moderate risk […]
Analytical Chemistry, Medical Device, Microbiology, Toxicology
The EU’s Medical Device Regulation (MDR)
The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be […]
Biologics
Gene Therapy – The Expanding Pipelines and New Draft Guidance Documents
Gene therapy has broken out of its chains. In 2017 alone, Kymriah (Novartis), Luxturna (Spark), and Yescarta (Kite Pharma/Gilead) received […]
Analytical Chemistry, Biologics, Medical Device, Pharmaceuticals
Pacific BioLabs Purchases SciEx TripleTOF 5600 High Resolution Mass Spec System
The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear
dynamic range. In highly complex matrices, the […]
Medical Device
Reusable Device Cleaning Validation – Three Cycles or One Cycle?
Pacific BioLabs have been performing reusable device cleaning validations for over a decade. Traditionally, PBL has performed cleaning validations by […]
Medical Device
FDA Decision to Exempt Certain Class II Devices from 510(k) Premarket Notification
On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet […]