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
