2800 Patton Road | Roseville, MN 55113

Regulatory

Regulatory Management

Successful regulatory submissions are the prerequisites for gaining market approval. Approved regulatory submissions for medical devices require explicit adherence to specific content and format requirements since every regulatory agency has unique requirements, and those complex requirements often change. Regulatory communications with the appropriate authority staff members may even be necessary for timely approval to guarantee successful regulatory submissions.

The Fang Consulting staff are specialists who understand the evolving regulatory affairs for medical devices. 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.

Our staff’s comprehensive knowledge of the regulatory submissions process appoints each regulatory affairs consultant as a leader for your company’s questions and needs.

Fang Consulting offers medical device regulatory submissions advisement at each step of your project. See below for a list of what our regulatory compliance consultant capabilities include.

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

Our staff’s expertise is vast in order to fulfill your project’s specific needs and support ongoing functions to strengthen your regulatory submissions. Our medical device regulatory consulting services ensure all your projects are handled by an expert.

  • Product Development Protocols (PDP)
  • EU MDR regulations and technical documentation
  • Protocols for post-market surveillance of medical devices
  • GSPR checklists
  • Labeling/labeling review
  • FDA and other Regulatory Authority meetings
  • Product team support to ensure devices meet regulatory and product safety standards
  • MDD to EU MDR strategic gap analysis
  • Regulatory strategy
  • Global regulatory compliance and registration guidance/support
  • Standard and guideline reviews and instruction
  • Establishment registration and device listing

The Fang Consulting team stays up to date on all global regulatory compliance changes to ensure your project follows with all necessary regulatory requirements. We use and implement medical device regulation solutions that enable efficient results.

  • Product support from concept through post-market activities
  • Ability to leverage industry best practices
  • Minimize potential product approval delays
  • Reduced likelihood of audit deficiencies or product recalls

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.

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.

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.

Who We Serve

Billion+

Fang Consulting’s advisory services provide partnerships for dependable and prompt results to address ongoing and new developments. Our team of experienced experts with diverse skillsets have the resources necessary to keep your projects on-time and on-budget to uphold your quality standard.

Midsize

Advance your midsize company by streamlining project production using our team’s expertise. Fang Consulting brings your operations to full capacity by filling the necessary gaps to contribute to the continued growth of your company, such as short-term staff augmentation consulting to QMS system management.

Startup

We mitigate the complications that startups’ experience when navigating the medical device industry by providing direct medical device strategy consulting at each fundamental stage. Fang Consulting gives you the confidence to enter the market knowing that your product and business are performing at the highest level.

Guiding Your Regulatory Submissions Process to Success