Medical Device Manufacturers-Help Getting Your Device to Market
Diana Gier
Founder
Medical Writer
Writer
Regulatory Affairs and Healthcare Compliance strategies, playbooks, reports and manuals.
Preparation of regulatory submissions to FDA: 510(k); Q-Submission; Premarket Approval (PMA); Breakthrough Device Designation (BDD); Humanitarian Device Exemption (HDE); Investigational Device Exemption (IDE); De Novo device
