Whether you are a start-up with a novel medical product or an international corporation with wide product distribution, Folio Consulting Group, LLC has the expertise to assist with your regulatory project management. In addition to Regulatory and Quality experts, FCG's team also includes specialists with project management experience.
We specialize in creating actionable project plans that highlight regulatory deliverables, while concurrently meeting marketing, sales, and distribution objectives and timelines. Reach out to us if you are in the early stages of developing your medical device and need a skilled project manager. We can also help lead your compliance management for addressing changes in the regulations, without consuming excessive time and internal resources. With changes such as the EU’s Medical Device Regulations (MDR), In Vitro Diagnostic Regulations (IVDR), and the 510(k) eSTAR Requirements, which will be required for all 510(k)s starting October 2023, now is the time to assess your compliance with future upcoming regulatory changes. Reach out to us for a free 30-minute initial consultation to discuss how we can help.