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 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.
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.
