We offer full-service regulatory and product development consulting services for In Vitro Diagnostics (IVD) Devices throughout all stages of the medical product life-cycle.
We offer full-service regulatory and product development consulting services for In Vitro Diagnostics (IVD) Devices throughout all stages of the medical product life-cycle.
- Investment Due Diligence
We can help you assess your investment interest in a medical device, IVD or life science product.
☑ Subject Matter Expertise Input on Technology/IP
☑ Assessment of Regulatory Landscape
☑ Market Validation, Assessment of Business Plan and Commercialization Strategy
- Product Development
We can help you take your idea for a medical device from concept to creation.
☑ Medical Product Research
☑ Medical Product Design
☑ Product Prototypes
☑ Protocol Development - Pilot, Feasibility, Validation
☑ Medical Product Research
☑ Medical Product Design
☑ Product Prototypes
☑ Protocol Development - Pilot, Feasibility, Validation
- Product Testing
We'll assist in product testing and clinical trials throughout the development process.
☑ User Studies
☑ Regulatory & Clinical Trials
☑ Marketing Surveys
- Commercialization
We have a proven track record of bringing products to global market.
☑ Market Assessments / Target Product Profile / Competitive Analysis
☑ Business plan development and/or review
☑ Global Regulatory Assessment / Submission / Labeling
☑ Manufacturing (Pilot to Scale)
☑ Market - go to strategy, global sales and distribution
☑ Exit Strategies
- Funding Activity Assistance
We can help you secure the funding you need to get your product off the ground.
☑ Dilutive and Non-Dilutive (Grants, Philanthropic Funding)
☑ Merger & Acquisition Activities
- Product Rescue
We can step in at any stage of development and help get your project back on track.
☑ Progress Analysis
☑ Project Management
☑ Goals & Benchmarks
☑ Budget & Timeline Evaluation
☑ Manufacturing Delays
☑ Regulatory Issues
No matter where you are in your In Vitro Diagnostic device development life-cycle, POCA International can help.
No matter where you are in your In Vitro Diagnostic device development life-cycle, POCA International can help.