Overview
Typical activities
- Customer / User / Patient discussion and collaborations
- Clinical evaluation
- Clinical studies
- Post-market clinical follow-ip studies
Typical activities
- Reimbursement strategy
- Business plan
- Health economics
- Market research / Opportunity
- Competitive analysis
- Funding opportunities
- Branding
- Sales
- Need identification
- Market / User requirements
Typical activities
- Literature reviews
- Customer complaints
- Need identification
- Customer / User / Patient discussions and collaborations
- Academic research
- Collaboration
- Technological discovery
- Innovation
Typical activities
- Packaging
- Labeling
- Installation requirements
- Manufacturing quality plan
- Supply chain
- Distribution
- Sterilization
- Prototyping
- Process development and validation
- Assembly
- Life cycle analysis
Typical activities
- Device classification (MDD, IVDD, AIMDD)
- Regulatory requirements
- Quality management system
- ISO 13485 certification
- Audits
- Customer complaints
- Competent authority / Notified body
- Vigliance handling
- Post-market surveillance
- Compliance to standards
Typical activities
- Mechanical and electrical engineering
- CAD
- Software development
- Biomedical and chemical engineering
- Industrial engineering and design
- Design verification and validation
- Requirements (e.g. functional, performance, interface)
Partners
Upcoming Life Sciences Events
- September 2026
- Rockville: BioHealth Capital Region Forum & Investment Conference
- Seoul: Korea Life Science Week
- Boston: RESI Boston 2026