Medical Device Consulting

PDG has provided medical device consulting services to firms located around the world since its founding in 1999. PDG offers one-stop-shopping to include 513(g) requests for information, pre-submission meetings (formerly pre-IDE meetings), IDE filing and Institutional Review Board (IRB) approvals, 510(k) and PMA submissions. Our expertise includes, clinical development in parallel with strategic regulatory planning and manufacturing and other third party vendor audits, compliance with FDA regulations, ISO 13485 Standards, Health Canada (CMDCAS) and European Union (MDD) requirements.

Exempt Devices/513(g) Submissions
Device Pre-submission Meetings and Reviews
Facility Inspection Readiness
Combination Device and Drug/Biologic Submissions
510(k) Submissions
PMA Submissions