2800 Patton Road | Roseville, MN 55113

Billion+

Billion+ Medical Device Companies

Fang Consulting provides the staff, knowledge, and skillsets so each of your projects stay on-budget and on-time. We have the capabilities to address your regulatory submissions and QMS system needs on an ongoing or case-by-case basis. Fang Consulting builds partnerships so your company has an informed and equipped team ready to answer questions and contribute resources.

As a Billion+ medical device company, Fang Consulting recognizes your unique needs and offers specific services that will contribute to the overall quality of your business and product. We bring value, from staff augmentation services to medical device strategy consulting, to support your day-to-day business.

Our Services

Regulatory Management

Medical device regulatory requirements continue to accrue new checklists and additional considerations. The Fang Consulting team stays alert and updated on all industry changes to provide superior advisement. Below is a list of what regulatory management services we offer.

  • RA/QA staff augmentation services
  • Short-term projects (6 mos – 3 yrs)
  • EU MDR strategic gap analysis
  • FDA submission support
  • EU submission support
  • ROW submission support
  • Process CO backlog (RA & QA review)

Quality Management

To uphold your company’s reputation, you need to maintain next-level quality across all products and functionalities. To maintain that standard, Fang Consulting has the staff and support to increase efficiencies. The following list addresses the key QMS consulting services we provide Billion+ companies.

  • RA/QA staff augmentation services
  • Short-term projects (6 mos – 3 yrs)
  • Third party ISO 13485 audits
  • Process CO backlog (RA & QA review)

"Our team of consultants has expertise in the most current global regulations and certifications."

We are your partner for continuous support and success