SOLUTION
MedTech Strategy
We expedite product launches and market adoption for your medical device from concept to clinical trials, through regulatory approval.
Our clients receive strategies and roadmaps ready for seamless implementation for each step of the process.
One size does not fit all!
We can guide you through the whole journey or we can meet you where you are or where you are struggling.
Comprehensive Market Access Strategies
We work with medical device companies who want to obtain regulatory approval to market their device. Our clients receive a comprehensive market strategy that includes targeted new product introduction (NPI) plan supported by reimbursement and expansion strategies.
Key Elements of our Market Access Solutions
Our Comprehensive Market Access Strategy is tailored for your device and company.
It outlines exactly how to bring your new or improved device to the market while avoiding regulatory hurdles.
We also develop strategies for market adoption after your device has launched.
- Indication expansion
- Reimbursement
- Healthcare adoption
Expand products to outside US markets (OUS)? Additional services include Clinical Evaluation Reports (CERs) and Post-market Follow-up (PMCF). We have market expertise in:
- United States
- Europe
- United Kingdom
- Canada
- Australia
- China
Global Regulatory Services
Our in-depth regulatory expertise and proactive engagement with regulatory authorities expedite the approval process, minimizing time-to-market and reducing the financial burden associated with prolonged regulatory pathways.
FDA Regulation
- Investigational Device Exemption (IDE)
- Premarket notification 510(k)
- Humanitarian Device Exemption (HDE)
- DeNovo
- Breakthrough device designation
European Regulation
- MDD to MDR remediation
- Notified body negotiations (TUV, BSI, DEKRA)
- CE mark applications
- CER & PMCF writing
Australian Regulation
- TGA engagements/negotiations
- ARTG conformity
- Public & private reimbursement standards
