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Medical Device

BioPoint, Inc. / Medical Device

BioPoint is a leading global Life Science consulting firm. We partner with Medical Device organizations to provide consulting services and flexible workforce solutions that help optimize product development from concept to post market. BioPoint’s expertise encompasses a wide array of therapeutic areas and all medical device classifications within the Regulatory, Quality, Clinical and Market Access / HEOR functions.

If you have questions about service areas listed or not listed below, please contact us.

Regulatory

  • Submission Filing Support
    • PMA
    • 510k
    • De Novo
    • IDE
    • HDE
    • Design Dossier/technical files for CE Mark
  • Regulatory Strategy
  • Post Market Support
    • Regulatory Agency Liaison (US/EU/CAN/ROW)
    • Warning Letters/483
    • Consent Decrees
  • Label Development/Expansion

Quality

  • Quality Management Systems (QMS) development and support
  • EU MDR/MDD compliance
  • Gap Analysis, Pre-Audit and internal/external Audit Support
  • Remediation of quality issues to address System Deficiencies, 483 Observations, Warning Letters and Consent Decrees
  • Product Complaint handling and MDR Vigilance
  • Development of SOPs, Quality Manuals, Work Instructions, Templates and Records

Clinical

  • Clinical Evaluation Services
    • Development of new CER’s
    • Update existing CER’s
    • Compliant with MedDev 2.7.1 Rev. 4
    • Compliant with EU MDR 2017/745
    • Literature reviews
  • Clinical Study/Trial Site Services
    • Study Design/Analysis
    • Site Selection, Qualification, and Initiation
    • Study Management
    • Site Monitoring
    • Event Reporting
    • Close-out Visits
    • Annual and Final Report Writing

Market Access / HEOR

  • Market Access Landscape
  • Pricing & Reimbursement Strategy
  • COA/PRO Design
  • Systematic Literature Reviews
  • Economic Models
  • Global Value Dossiers
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