PDG Has Provided Medical Device Consulting Services to Firms Around the World Since 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
Contact us for help with your medical device development, Medical Device Consulting and compliance needs.