Medical Device Consulting

Medical Device Consulting

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…

Device Pre-submission Meetings and Reviews with CDRH

There are a number of pre-submission meetings and review procedures available to the device industry seeking advice from FDA during the developmental stages of IDEs, 510(k)s and PMAs. PDG can help maximize the value of your interactions with CDRH through the 510(k) Pre-Submission Program, pre-IDE Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission…

FDA Facility Inspections - Readiness and Mock FDA Audits

FDA Facility Inspections – Readiness and Mock FDA Audits

To help prepare for FDA facility inspections, PDG device consultants are available to review, improve and implement quality control, quality assurance, document control, and complaint handling procedures. Improve FDA Facility Inspection Readiness with Mock FDA Audits We also prepare our clients for FDA inspections by conducting mock audits to include third party facilities such as,…

Combination Device and Drug/Biologic Submissions

Generally speaking, a combination product is composed of any combination of a device/drug, device/biologic, drug/biologic or combination of all three, including co-packaged products. Combination products are often confused with fixed combination dose (FCD) drug products, which are comprised of drug/drug combinations. Because PDG’s team of device consultants and pharmaceutical consultants possess industry expertise in the…

510(k) Submissions

PDG’s 510(k) compilation consists of a series of steps designed to ensure that CDRH accepts the filing. The first step is to determine (to the extent possible) that the 510(k) is the most appropriate regulatory pathway including whether traditional, special or abbreviated 510(k). This is followed by a data review of the device records, comparing…

Florida Based Medical Device Consultant on 510(k) Submissions

Florida Based Medical Device Consultant on 510(k) Submissions

As a medical device consultant, PDG takes great interest in the ever-changing landscape of the premarket notification (510(k)) review and clearance process.  Besides the significant scrutiny given to the program over the past five years, the vast majority of legally marketed medical devices in use in the U.S. today were cleared via the 510(k) regulatory…