Fang Consulting
Fang Consulting specializes in medical device strategy, regulatory affairs, and quality assurance. They provide customized consulting services to help clients navigate complex regulations, achieve compliance, and bring medical devices to market efficiently. With over 20 years of experience, their team offers both on-site and remote support, focusing on successful regulatory submissions, quality management systems, and global market entry. Their mission is to serve as a trusted partner in solving pressing regulatory and quality challenges, ensuring client success in the medical device industry.
Industries
Nr. of Employees
small (1-50)
Fang Consulting
7803 Glenroy Road, Suite 100 | Bloomington, MN 55439
Services
Preparation, filing, and management of 510(k) premarket notifications including predicate analysis, product code selection, gap analysis, performance data review, and FDA communications support.
Regulatory planning and execution for De Novo, PMA, and IVD submissions, including pathway selection, preparation of pathway-specific documentation, and submission management.
Design, implementation, and remediation of quality management systems and corrective action plans to achieve and maintain regulatory compliance.
Planning and preparation of post-market surveillance activities, PMCF studies under EU MDR, and periodic safety update reports for continuing regulatory compliance.
Support for EU MDR conformity activities, EUDAMED data registration, and preparation for notified body interactions.
Assessment and remediation planning for FDA Form 483 observations and warning letters, including CAPA planning and regulatory response preparation.
Preparation, filing, and management of 510(k) premarket notifications including predicate analysis, product code selection, gap analysis, performance data review, and FDA communications support.
Regulatory planning and execution for De Novo, PMA, and IVD submissions, including pathway selection, preparation of pathway-specific documentation, and submission management.
Design, implementation, and remediation of quality management systems and corrective action plans to achieve and maintain regulatory compliance.
Planning and preparation of post-market surveillance activities, PMCF studies under EU MDR, and periodic safety update reports for continuing regulatory compliance.
Support for EU MDR conformity activities, EUDAMED data registration, and preparation for notified body interactions.
Assessment and remediation planning for FDA Form 483 observations and warning letters, including CAPA planning and regulatory response preparation.
Expertise Areas
- Regulatory strategy and submissions (510(k), De Novo, PMA, IVD)
- EU MDR compliance and EUDAMED registration
- Post-market surveillance and post-market clinical follow-up (PMCF/PSUR)
- Quality management system design and remediation
Key Technologies
- 510(k) premarket notification
- De Novo classification pathway
- Premarket Approval (PMA) submissions
- In vitro diagnostic (IVD) regulatory processes