Go to Client Portal

Heidi Busz, MS

Regulatory Consultant

Reserve your Consultation with our Experts

Contact Us

Heidi Busz has eight years of experience in the medical device industry supporting new product development and product lifecycle management. Heidi began her medical device career with Zimmer Biomet focusing on sterilization, cleaning, disinfection and durability validation and verification. Since receiving a Master’s Degree in Orthopaedic Regulatory and Clinical Affairs, she has accumulated six years of direct regulatory experience in the orthopaedic industry. Heidi moved into a consultancy role with NAMSA in 2021 where the focus of her work is on supporting manufacturers and specification developers of a broad range of medical device technologies with change impact assessments, Food and Drug Administration (FDA) regulatory strategies and FDA submissions. 


  • Development of global regulatory strategies for entry into key Sponsor markets and to achieve product lifecycle maintenance
  • Oversight of Gap Analysis of regulatory submissions and source documentation, in addition to authoring and managing FDA submissions (via strategy/resolution development for FDA interactive and Artificial Intelligence [AI] requests)
  • Management of MDR transition team, including overall strategy and execution of MDR deliverables
  • Authoring and maintaining EU technical documentation, as well as corresponding and developing conformity resolution with EU Notified Bodies and authorized representatives
  • Preparation and review of Clinical Evaluation Reports (CERs) to MEDDEV 2.7/1 Rev 4 and MDR requirements
  • Executing regulatory due diligence throughout business acquisitions, including Gap Assessment and harmonization efforts
  • Supporting original and supplemental international submissions/registrations/change notifications
  • Supporting front and back room needs during FDA inspections and Notified Body audits
  • Authoring QMS Gap Assessments and procedures in accordance with ISO 13485 and 21 CFR 820
  • Overseeing multiple manufacturing and cleanroom processes for quality control and cleanability / sterility assurance 


  • Traditional and Special 510(k) Projects: successful outcomes with U.S. FDA clearance for Client
  • Post-IDE-Approval Projects: Sponsor coordination to ensure timely submission of necessary IDE amendments, supplements and annual reports
  • Regulatory Strategy and Pre-Submission Projects: development of regulatory strategies that identify and seek to rectify weaknesses/risks to a successful outcome; engaged FDA for feedback via the pre-submission process to best position Client device and support data for future premarket submission