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Your Quality Management is your Reputation

Establishing a Quality Management System is a critical requirement of manufacturing high integrity products.

Fang Consulting professionals monitor and study the ever-changing global quality and compliance requirements of international regulatory authorities, including the FDA and the EU. We partner with clients to ensure that medical products comply with ISO 13485 and all applicable product safety standards.

We will partner with you to establish the QMS you need to prevent manufacturing deficiencies which may result in product recalls.

Expertise Provided

Quality and Compliance expertise:

  • Quality Management System (QMS) Development, Maintenance, Improvement, & Support
  • Selection and Interpretation of US and International QMS Requirements
  • Drafting ISO 13485 and ISO 9001 Quality Manuals and Procedures
  • ISO 13485 and ISO 9001 Auditing
  • Conducting Gap Analyses
  • Quality Supplier Audits
  • Assessing Applicable Product Safety Standards and Developing Product Safety Test Protocols
  • EU MDR / MDD Compliance
  • Developing Electronic Medical Device Reporting (eMDR) and European Vigilance Reporting Systems
  • Outsourced Quality Assurance for virtual companies
  • Communications for Product Field Actions (Safety Alerts, Product Recalls, Corrective Actions)
  • And more

Quality Management System (QMS) Questions?

Reach out to Fang Consulting and a Consultant/Strategist will followup with you.