Medical Devices
  • The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 510k, unless exempt or Premarket Approval (PMA)
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality system (QS) regulation
  • Labeling requirements and Medical Device Reporting (MDR)
 
  • Regulatory control increases from Class I to Class III and that's where Regsource Consulting can help. The services we provide to the Medical Device industry includes, Regulatory Strategy, Regulatory Operations, Clinical, Nonclinical , CMC, Compliance and Regulatory Project/Program Management consulting (please click on the highlighted links for additional services information) These services include
  • Product Development Planning
  • Strategy for Agency Meetings
  • Due Diligence Support
  • National and International Regulatory Submission Support
  • Regulatory Classifications, Applications and Submissions
  • Response to Regulatory questions
  • Product Development Strategy
  • Regulatory Submission Management Support
  • GXP implementation strategies
  • Responses to Agency Questions
  • Clinical Trial Design and Management
  • Review of Clinical Sections of submissions
  • Provide ongoing regulatory oversight of clinical trials
  • Pharmacology and Toxicology program review and development
  • Preparation and review of all CMC sections for regulatory submission
  • Assistance in validation activities
  • Quality Systems Assessment
  • Advertising and Promotional Compliance
  • Regulatory Agency Inspection Preparation
  • GXP Audits
  • Regulatory Product Project Management
 
  • Whether you are searching for advice on developing a Premarket Notification 510k, or Premarket Approval (PMA) or setting up manufacturing suites or performing clinical trials, we can help you achieve your goals within your timeline.
  • Contact us and find out how RegSource Consulting help.