Meet compliance requirements, minimize the risk of failure, and increase your speed to market in today’s complex regulatory landscape with the guidance of Pace’s FDA consultants.  

Prior to market sale in the United States, medical devices are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. To accurately apply these the regulatory controls and marketing pathways needed, compliance strategies are based on the risk of the device to ensure reasonable assurance of safety and effectiveness. 

Common Medical Devices Marketing Pathways:

  • Premarket Notification 510(k)
  • De Novo Classification Request
  • Exempt
  • Premarket Approval (PMA)
  • And More

Consulting Solutions and Services: 

Regulatory Strategy and Planning

  • Device Classifications
  • Special Controls Requirements
  • Biocompatibility Requirements
  • Human Factors and Usability Requirements 
  • Electrical Safety and electromagnetic Compliance (EMC) Requirements

 

FDA Submissions

  • Premarket Approval (PMA) 
  • Premarket Notification 510(k) 
  • Emergency Use Authorization 
  • Investigational Device Exemption (IDE) 
  • FDA Pre-Submission Conferences Meetings 
  • 513(g) Submissions, Requests for Classification 

 

Quality Management System Compliance

  • ISO 13485 & MDSAP
  • QMS Assessment and Audit 
  • Electronic QMS Implementation 
  • ISO 14971 Medical Device Risk Management  
  • Quality System Development and Maintenance 
  • Standard Operating Procedure (SOP) Development
  • FDA 21 CFR Part 820 Quality System Regulation (QSR) 

 

U.S. FDA Agent Services 
CE Mark and EU Technical File 

Contact me to learn more!

 
April Long
April Long | Sales Manager, Regulatory Services