Fang Consulting

Established in 1999, Fang Consulting provides Regulatory Affairs and Quality Assurance consultancy services to medical device manufacturers. From start-ups to global industry leaders, our established presence ensures efficiency, covering both pre-market and post-market device phases. We assist clients in navigating the complex nature of the regulatory landscape. Fang Consulting ensures compliance with medical device laws and regulations in every geography throughout the product lifecycle.

Regulatory Affairs

Ensuring compliance with current regulations is an essential part of bringing medical devices to market. Our consultants are experts in navigating the complex world of device regulation. From FDA 510(k) submissions to CE markings, our team guides clients through each step of the design process, ensuring robust test plans to ensure that your product attains and maintains compliance with global standards throughout its life cycle.

Quality Assurance

In today’s competitive marketplace, ensuring the highest level of product quality is non-negotiable. Our consultants offer dynamic solutions that empower businesses to achieve excellence in every aspect of their products. A robust Quality Management System is critical to ensuring that a medical device is safe, effective, and meets customer and regulatory requirements. The consultants at Fang build and maintain comprehensive Quality Management Systems that minimize the risk of product recalls and reduce costs associated with quality issues.

Global Submissions

Fang Consulting has driven hundreds of product registrations in countries such as Canada, Central and South America, Africa, Australia, and APAC countries. Our experience and knowledge of the dynamic and fast-changing world of global compliance standards helps ensure that regardless of the area you intend to sell into, you have the appropriate technical documentation and submission content to reduce registration delays and maintain the fastest pathway to market.

CAPA’s and FDA Form 483’s

Quality issues resulting in CAPAs (Corrective And Preventive Actions), reportable adverse events, product recalls, and warning letters (FDA Form 483s) can significantly delay our client’s ability to sell products to their desired marketplaces. Fang Consulting offers remediation services to manufacturers who’ve received post-market actions from global regulating bodies. Our team completes detailed assessments to uncover gaps within Quality Management Systems while effectively managing employee training on applicable standards to provide our clients with a robust remediation roadmap to ensure a quick return to the market.

The Fang Advantage

We are a highly experienced team with a proven track record of excellence. Our staff averages over ten years of industry experience per consultant with international Fortune 500 clients.

Most Fang staff members are in the office every day. Although clients will have a singular point of contact, the entirety of the knowledge base at Fang Consulting is at our client’s disposal. 

Clients never have to wait long for a response from our team. We pride ourselves on open and fluid communication to complete all projects and provide the highest level of customer service quickly and efficiently.

Press Releases

Time is Running Out: All MDD Certificates Expire May 26th, 2024