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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 classifications for devices, combination products and diagnostics. BioPoint’s customized offerings include both strategic leadership and tactical support within the Regulatory, Quality, Clinical, Safety & Surveillance and HEOR / Market Access functions.

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

Clinical

  • Study Design/Analysis
    • Biostatistics & Programming
  • Site Selection, Qualification, and Initiation
  • Study Management & Vendor Oversight
  • Clinical Data Management
  • Medical Writing – Clinical & Regulatory
    • Protocols, IB’s, ICFs, CRFs, Monitoring Plans, CSRs, Scientific Publications, etc.
  • Clinical Evaluation Strategy and Writing – EU MDR / IVDR
    • Gap Assessment & Transition Roadmap
    • Literature Reviews
    • Clinical Development Plans (CDPs)
    • Clinical Evaluation Plans (CEPs)
    • Clinical Evaluation Reports (CERs)

Regulatory

  • Regulatory Strategy and Health Authority Interaction
    • Preparation & Facilitation for Regulatory Body Correspondence (US/EU/ROW)
    • Submission Planning, Launch and Post-approval Guidance
      • PMA/510k/De Novo/IDE/HDE/Design History File
      • Design Dossier/Technical Files for CE Marking
  • Regulatory Operations
    • Submission Development & Formatting
    • Packaging, Labeling and Artwork Solutions
    • User Manual Updates
    • UDI
  • Regulatory Intelligence & Policy
    • Global Landscape Surveillance
    • Optimization of New & Existing Marketing Privileges

Quality

  • Navigation of Domestic and International Standards / Regulations
    • 21 CFR Part 820 & 13485 integration, Part 11
    • ISO 13485, 9001, 14971
    • IEC 60601, 62304, 62366
  • Strategic Planning for EU MDR / IVDR Adoption
  • Quality System Implementation and Maintenance
  • Software & System Validation
  • Auditing and Inspection Readiness (MDSAP,FDA,ISO)
    • Virtual & On-site Capabilities
    • Gap Analysis
    • Mock & Pre-audits
    • Internal Audits
    • Supplier Audits
  • Remediation of Quality & Compliance Issues

Safety & Surveillance

  • AE/SAE & Product Complaint Assessment, Investigation and Reporting
    • Safety Database Support via case system migration, transition and/or upgrade
    • Development of robust surveillance tools
  • Develop and Review of key clinical & post-marketed Risk Management documents
    • Risk Management Plans & Reports
    • Product Hazard Assessments & Evaluations
    • Design FMEAs
  • Prepare safety statements for relevant communications purposes such as DHCP letters
  • Author required surveillance documents – PSURS, PMSP, PMSRs, SSCPs, PMCFs, etc.
  • Signal detection and monitoring medical safety profile for pre & post-marketed products
  • Epidemiological Research & Design

HEOR & Market Access

  • RWE Generation Strategy and Analysis Supporting Value Proposition
    • Observation Study Design
    • COA Development & Validation
    • Economic Modeling, Statistical Analysis and Programming
      • Cost-effectiveness
      • Budget Impact
    • Global Value Dossier Development
    • Publication, Manuscript and Abstract Design
  • Global Market Assessment Ensuring Successful Product Positioning
  • Coverage & Reimbursement Analysis, Strategy and Implementation
    • Payer Mix Selection through Patient Demographics and Site of Service analysis
    • Influential Stakeholder Identification & Interaction
    • Regulation / Policy Navigation
    • Coding Assessment & Development Activities
      • CPT, ICD, HCPCS
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