2800 Patton Road | Roseville, MN 55113

Midsize

Midsize Medical Device Companies

As a midsize company in the medical device industry, you often face the dilemma of being short-staffed during a busy period, lacking the necessary expertise for a specific project, or not having enough bandwidth to deal with an urgent situation. Fang Consulting has a team of experts with diverse experience in the medical device industry to counter those staffing situations. We make sure your temporary replacement needs (employee or maternity leave) or short-term projects (6 months to 3 years) are covered. Our team’s staff augmentation consulting can lead, advise, and adhere to the roles your company needs to be filled.

Fang Consulting provides direct advisement on medical device regulation and quality management to address pressing concerns and safeguard future performance. We are your medical device consulting partner to grow your business to exceed product reliability and business operations.

Our Services

Regulatory Management

From filing the gaps in your team or providing support for regulatory submissions, Fang Consulting offers regulatory management services that reflect the advancing global changes and unique agency requirements. Below is a list of regulatory strategy services we provide for midsize companies.

  • RA/QA staff augmentation
  • Person Responsible for Regulatory Compliance (EU MDR Article 15)
  • EU MDR strategic gap analysis
  • FDA submission support
  • EU submission support
  • ROW submission support
  • Process CO backlog (RA & QA review)

Quality Management

The team at Fang Consulting has the knowledge and skillset to fill staffing needs or manage quality systems regulations. Advancing your certified quality management system and its responsibilities is critical for upholding an approved product. Some QA management services that we provide include the following.

  • RA/QA staff augmentation
  • Third party ISO 13485 audits
  • Process CO backlog (RA & QA review)
  • Quality system support/SOP creation
  • Supplier quality audits

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

Learn how we can help support and advance your company