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.

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

Expertise

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

Benefits

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 will become mandatory on 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

IVDR Consulting

The IVDR compliance requirements take effect on May 26, 2022, is your company prepared?

The In Vitro Diagnostics Regulation (IVDR) requires most IVD medical device manufacturers to obtain a CE Mark through a EU Notified Body. Our consulting services will make sure your company is fully prepared for the new regulatory requirements.

Learn more

EUA Consulting

Per the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Food and Drug Administration allows for the emergency use of some medical products under certain circumstances. An Emergency Use Authorization (EUA) provides FDA with the authority to support emergency preparedness and response, including supporting the development and availability of unapproved or new medical products (drugs, biological products and medical devices) for use in emergency situations.

Learn more

Need a project completed? We have an expert for that.

Contact Us