Pearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop provides an opportunity to hear from experts who...
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 definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much is easy to understand: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are...
Pearl Pathways is excited to be attending and presenting at the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies...
FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...