by Sarah Wesp | Feb 16, 2015
Pearl Pathways’ own COO and Co-Founder, Gretchen Bowker will be holding a webinar on FDA regulatory requirements for the manufacturing and commercialization of dietary supplements via ComplianceOnline. A few of the topics include a review of FDA regulations in the...
by Sarah Wesp | Feb 16, 2015
The British Standards Institution (BSI), the world’s first national standards body to partner with medical device manufacturers is holding its second annual Mini-Roadshow program on April 16th. The event topics include: European Regulatory Update – CE, 13485,...
by Sarah Wesp | Feb 4, 2015
Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus. The full article can be found on RAPS.org (Login and Password required) and is entitled “Types of In Vitro Diagnostics: Clearing Up the...
by Sarah Wesp | Jan 29, 2015
Pearl Pathways is excited to sponsor its Asia partner and attend upcoming Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations. This conference provides an opportunity to network and hear first-hand accounts from several...
by Sarah Wesp | Jan 28, 2015
FDA has released a draft guidance on its new approach for defining and classifying new medical device accessory types. Device accessories have previously been classified in congruence with the parent device or as a completely separate classification regulation. The...