From ideation to market dominance
Fission Consulting accelerates your MedTech venture through expert consulting, ensuring seamless development, successful launch, and sustained excellence.
At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.
Solutions for Every Milestone of Your Journey
Commercializing a medical product is a complex and multifaceted endeavor. At Fission, we’ve developed six Market Access Pillars to support every step of your MedTech venture from concept, to your first sales, and beyond.
If you only need a website designed, quality procedures developed, or a full 510(k) submission, we’ve got you covered.
OUR SERVICES
Market Access Pillars
Design & Development
- Project Management
- Usability Engineering
- Design History File Creation
- Verification & Validation
- Risk Management Planning
Clinical Development
- Clinical Protocol Development
- GCP Compliance
- Clinical Evaluation Reports
- Data Integrity & Management
- Post-Market Clinical Studies
Quality Systems & Compliance
- Quality Management Strategy
- Quality Management Systems
- Mock FDA Inspections
- Regulatory Audit Prep
- Compliance Training
Regulatory Affairs
- Regulatory Strategy
- FDA Submissions Support
- Regulatory Gap Analysis
- Global Submission & Registration
- Regulatory Compliance
Commercialization
- Brand Development
- Strategic Marketing Planning
- Content Strategy & Creation
- Digital Marketing
- Social Media Management
Post-Market Support
- Post-Market Surveillance
- Continuous Quality Improvement
- Product Lifecycle Management
- Regulatory Reporting
- Complaint Management
