855.554.5BIO info@biopointinc.com
Medical Devices

 

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. 

Specialties

Specialization, Flexibility, Results

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

Contact Us
Case Study

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