MedTech
Uncompromising Global Specialist in Medical Device & Diagnostics
Dedicated MedTech team with 30-year history combines medical device, diagnostic, in vitro diagnostics, and medtech services expertise that understands the nuances of medical device and diagnostic trials, along with medtech consulting. Our client-focused Medtech CRO team uses an agile approach from step one to submission to deliver an exceptional trial experience.
Global regulatory success
Successful agency interactions provide valuable insights into the current environment
Expert MedTech team
Access a dedicated medical device and diagnostic team with a global footprint and flexible sourcing models.
Streamline ISO 13485 compliance
Follow key quality system requirements to simplify audits and reduce development burdens.
Medtech services—advancing healthcare
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 changing regulatory environments globally and a keen understanding of efficient and effective trial design to achieve your goals. That’s why we established a 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.
MedTech experience that matters
In the last 5 years, we have supported:
Our MedTech team – advancing your goals
Drawing from our experience advancing more than 721 device and diagnostic trials run in the last five years, our team at Fortrea is equipped to help. Our team has led several medical device and diagnostic studies since 1985. Our knowledgeable staff has, on average, 18 years of medical device and diagnostics experience
Streamline your path to market
Our MedTech regulatory affairs professionals work with you to design an optimized development plan 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. Post-launch, we help you meet changing regulatory requirements and post-market study needs efficiently.
From MedTech Innovation to Approval: Your Roadmap to smooth 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 the value of each development stage. Our regulatory specialists identify potential compliance issues early, leveraging global regulatory experience to achieve regulatory approval/clearance in your target markets.
Streamlined Trials for Accelerated Market Access
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. Collaborate 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
- Lab testing
- 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
- Medical review
- Aggregate reporting
- Safety surveillance
- Label changes
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Strategy
- Regulatory strategy planning
- Claims and labeling
- Portfolio management
- Project management
- 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
- Clinical Evaluation Reports (CERs)
- 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
MedTech-related frequently asked questions
Choose the level of oversight and accountability you need.
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What is MedTech?
MedTech, short for medical technology, encompasses a wide range of products and services used to diagnose, monitor, and treat medical conditions. MedTech services includes medical devices, software, diagnostics, and digital health solutions.
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How is MedTech different from Digital Health?
Digital Health is a broader term that includes mobile health apps, telemedicine, and health IT, while MedTech clinical solutions focuses more on physical devices and technologies used in clinical settings.
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How is AI being used in MedTech?
AI is used for diagnostics, predictive analytics, robotic surgery, and personalized treatment plans. However, it requires rigorous validation due to regulatory and safety concerns
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What is the difference between 510(k) and PMA in the U.S.?
510(k): A faster approval process for devices similar to existing ones.
PMA (Pre-Market Approval): A more rigorous process for new or high-risk devices.
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What are the biggest challenges in MedTech commercialization?
- Navigating complex regulations
- Securing funding
- Demonstrating clinical and economic value
- Gaining reimbursement approvals
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What are the current trends in MedTech healthcare?
- Miniaturization of devices
- Integration of AI and machine learning
- Wearable health tech
- Remote patient monitoring
- Personalized medicine 3
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What is the future of MedTech innovation?
The industry is moving toward smarter, more connected, and patient-centric solutions, with a strong focus on data-driven care and global accessibility.