医療技術
Insights and know-how to advance your MedTech.
Our dedicated MedTech team combines medical device and diagnostic and in vitro diagnostics expertise with the resources of a global world-class CRO to drive your development forward. Accelerate your MedTech innovations.
Global regulatory success
Enable an optimized global regulatory strategy from preclinical to your product’s launch—and beyond.
Expert MedTech consultants
Access dedicated medical device and diagnostic consultants and the reach of our global organization.
Streamline ISO 13485 compliance
Follow key quality system requirements to simplify audits and reduce development burdens.
Our MedTech team—advancing your goals
The requirements needed to develop medical devices and diagnostic products-and successfully bring them to market-continue to evolve. This necessitates a deep knowledge of the evolving regulatory environments globally and a keen understanding of efficient and effective trial design to achieve your goals. That's why we established a dedicated medical device division as part of our global CRO. We consult and support you with the insights and experience needed to maximize your device's potential.
Drawing from our experience advancing more than 740 device and diagnostic trials run in the last five years, our team at Fortrea is equipped to help. Our team has led hundreds of medical device and diagnostic studies since 1985. Our knowledgeable staff has on average 18 years of medical device and diagnostics experience and six years of tenure at Fortrea.
MedTech experience that matters
In the last 5 years, we have supported:
Streamline your path to market
Our MedTech regulatory affairs professionals work with you to design an optimized development path that aligns with your clinical and commercialization objectives. This seamless plan integrates preclinical and clinical activities to help advance your product launch. We infuse market considerations to give you the edge you need in your target treatment area. Postlaunch, we help you meet changing regulatory requirements and post-market study needs efficiently.
Powerful planning for smooth MedTech development
Innovative technology is just the beginning; you need a solid, adaptable development plan. We help you build compelling evidence and a convincing value proposition, maximizing each development stage. Our regulatory specialists identify potential compliance issues early, leveraging global regulatory experience to achieve regulatory approval in your target markets.
Elevate your efficiency
Every trial is unique, and thoughtful trial design and execution are key to gathering sound scientific evidence. Our optimized study execution delivers the evidence you need for your submission while saving you time and money during the operational phase. Our advisors' deep experience helps identify ways to improve efficiency and reduce timelines. They also assist in pivoting your strategy if unexpected findings occur. Partner with us from the start to streamline processes and shrink your time to market.
Comprehensive support for your product
Our medical device and IVD teams handle the entire clinical process from start to finish.
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Clinical Trial Safety
- Site selection
- Protocol design
- ラボ検査
- Real-time adverse events monitoring
- Benefit/risk profile monitoring
- Regulatory submissions
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Post-Marketing Safety
- Global post-market vigilance
- Medical contact center
- Case processing
- 医療評価
- 集約レポーティング
- 安全性の監視
- Label changes
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戦略
- Regulatory strategy planning
- Claims and labeling
- Portfolio management
- プロジェクト管理
- Agency meeting support
- Post-market clinical follow-up plan support
- Design control support
- Risk management support
- Regulatory compliance consulting
- Registration and licensing support
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Writing
- 臨床評価レポート（CER : Clinical Evaluation Report）
- CE support: Tech file/design dossier
- Opinion letters
- Strategy documents
- Agency responses
- Audit preparation and support
- 483s and warning letters
- Biological safety evaluation
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Submissions
- 510(k)
- De novo
- FDA electronic medical device reporting
- PMA
- IDE
- Q-sub