2800 Patton Road | Roseville, MN 55113

Quality

Quality Management Systems

Establishing a certified Quality Management System (QMS) is a critical requirement for manufacturing high integrity products. Yet, the process of upholding compliance with regulatory submissions demands detailed and ongoing advisement. Your QMS system needs to operate at full-capacity to safeguard and grow your company, that’s why our QMS consulting experts are equipped with the knowledge and experience to instill a first-rate, certified quality management system.

Fang Consulting professionals monitor and study the ever-changing global quality and compliance requirements of international regulatory authorities, including the FDA and the EU medical device regulation.

We partner with clients to advise effective medical quality assurance (QA) management, such as ensuring products receive an ISO 13485 certification, meet the requirements for ISO 9001, and all other applicable product safety requirements. Fang Consulting provides you with a quality assurance consultant to advise and construct all components of a certified quality management system to guarantee compliance and build results.

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.

  • Certified quality management systems (QMS) development, maintenance, improvement, and support
  • Selection and interpretation of US and international QMS requirements
  • Drafting quality manual ISO 13485 and ISO 9001
  • Audit for quality management system ISO 9001
  • Audit for quality management system ISO 13485
  • Conducting a strategic gap analysis
  • Quality supplier audits
  • Assessing applicable product safety standards and developing product safety test protocols
  • EU MDR compliance
  • Developing Electronic Medical Device Reporting (eMDR) and European Vigilance Reporting Systems

From filling in the gaps or establishing a team, Fang Consulting’s staff will undertake any challenge or guide all projects by developing a QMS system that addresses the short-term solution while equipped with long-term benefits.

  • Prevent manufacturing deficiencies
  • Prevent product recalls
  • Build a robust and dependable QMS system
  • Implement best practices
  • Fill and close all compliance gaps

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.

Our QMS Consulting Advises Long-Term Benefits