QUALITY MANAGEMENT

The features and benefits of your product won’t matter if there is no integrity in your manufacturing — integrity that rests on the foundation of your quality management system (QMS).

Our consultants are well versed in the US quality system regulation (21 CFR 820) and the requirements of the ISO 13485 and 9001 standards. We also have a deep working knowledge of EU MDR and other international regulations. We can help you build and maintain a first-rate quality management system that complies with the regulations of the markets where you want to sell.

Upholding compliance.

You can’t grow your business without integrity, and you can’t scale up production to support that growth without a strong quality system. Your QMS is the foundation for the good manufacturing practices (GMP) that consistently produce a quality product, making it crucial to the financial health of your company.

Don’t leave quality to chance. In a competitive market, an effective QMS should be a critical piece of your business strategy. A solid quality plan will allow you to bring products to market faster, meeting both customer expectations and regulatory requirements while achieving commercial success.

The team at Fang Consulting has over forty years of combined experience in developing and executing all aspects of a robust quality management system, including conformity assessments, supplier audits, product safety protocols, electronic medical device reporting (eMDR) and more. Whether you need a complete QMS build or simply want to refine and improve and existing one, we can help.

Expertise

You can’t outsource quality, but you can outsource the talent needed to achieve your quality objectives. Our specialists understand each of the roles and responsibilities required by a certified quality management system and can step seamlessly into each one. Whether part time or full time, one consultant or an entire team, Fang Consulting’s specialists have expertise in the following areas:

  • Certified quality management systems
    (QMS) development, maintenance,
    improvement, and support
  • Conducting a strategic gap analysis
    Quality supplier audits
  • Selection and interpretation of US and
    international QMS requirements
  • Assessing applicable product safety
    standards and developing product
    safety test protocols
  • Drafting quality manual ISO 13485 and
    ISO 9001
  • EU MDR compliance
  • Audit for quality management system
    ISO 9001
  • Developing Electronic Medical Device
    Reporting (eMDR) and European
    Vigilance Reporting Systems
  • Audit for quality management system
    ISO 1348

Benefits

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
  • Conducting a strategic gap analysis
    Quality supplier audits
  • Selection and interpretation of US and
    international QMS requirements
  • Assessing applicable product safety
    standards and developing product
    safety test protocols
  • Drafting quality manual ISO 13485 and
    ISO 9001
  • EU MDR compliance
  • Audit for quality management system
    ISO 9001
  • Developing Electronic Medical Device
    Reporting (eMDR) and European
    Vigilance Reporting Systems
  • Audit for quality management system
    ISO 1348

Quality Assurance

Quality assurance can be a daunting responsibility, but you don’t have to go it alone. We can provide one or more quality assurance consultants to advise, guide, and help construct every component of a quality management system that will guarantee compliance and produce results you can see.

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