REGULATORY AFFAIRS

The Fang Consulting staff are specialists

who understand the evolving

regulatory affairs for medical devices.

Gain Market Approval

We are experts at creating and presenting submissions for approval by worldwide regulatory agencies. Each of our regulatory compliance consultant experts has decades of cumulative experience and is collectively responsible for hundreds of successful submissions.

510K

MDR

IVD

IVDR

PMA

Capabilities

Fang Consulting’s professionals are QMS consulting and quality assurance specialists that understand and assume each responsibility in order to establish a certified quality management system (QMS) for your company. Below are areas that our experts cover.

510(k) process and 510(k) clearance
Technical File and Design Dossier for
CE marking
Pre-IDE/IDE Submissions
(Investigational Device Exemption)
CE mark requirements
PMA requirements applications
CE mark approval
De Novo review

EU MDR Consulting

The new EU MDR requirements are mandatory as of May 26, 2021. Has your company transitioned yet?

Fang Consulting will advise and guide your company on how to address and comply with the new EU Medical Device Regulation (MDR) requirements. We make the transition efficient and dependable.

Learn more