医疗器械研发

Dedicated insights and know-how to advance your med tech

Enable an optimized global regulatory stategy from preclinical to your product launch and beyond.

Access dedicated medical device consultants and the reach of our global organization.

Follow key ISO 13485 quality system requirements to simplify audits and reduce development burdens.

Work with our dedicated medical device development team.

Developing medical devices demands a particular set of skills. Global regulatory requirements are medical device specific, as are the specifics of protocol design and study conduct, quality systems demands and commercialization considerations. That's why Fortrea established a dedicated medical device division as part of our global CRO to consult and support you with the insights and experience needed to maximize the potential of your device.

Our partnership enables the scale and reach of our established global organization, giving you the strength and flexibility you need to proceed with confidence.

Optimize your development path, from end to end.

Our development support team, led by regulatory affairs professionals, works with you to create an optimized development path that meets your clinical and commercialization objectives.

This plan translates into the seamless flow of preclinical and clinical activities required for an efficient and successful product launch. And, because market considerations are infused into your plan, the evidence gathered will provide the edge you need in your product's target therapy area.

Once your product is on the market, we're here to help you meet changing regulatory requirements and post-market study needs in a cost-effective manner.

Drive medical device development with global regulatory expertise.

医疗器材的创新技术仅仅是开始。您还需要一项可靠的研发计划，并随着此过程的推进不断调整。具有说服力的证据和令人信服的价值主张至关重要。竞争重点和利益相关方对价值的不同定义需要相互关联的创新策略，从而使研发每个阶段的价值最大化。 And, as evidence is gathered, it informs and iterates regulatory, reimbursement, clinical and post-market strategies.

我们的法规专家会及早行动，审视法规合规性的各个方面，以确定可能影响您的设计、材料、制造方法或财务计划的潜在问题。凭借在与全球监管机构打交道的过程中积累的丰富经验，我们可制定新颖的针对性策略，帮助您在目标市场获得监管部门的批准。

策略

Regulatory strategy planning
Claims and labeling
Portfolio management
项目管理
Agency meeting support
Post-market clinical follow-up plan support
Design control support
Risk management support
Regulatory compliance consulting
Registration and licensing support

Writing

临床评估报告(CER)
CE Support: Tech file/design dossier
Opinion letters
Strategy documents
Agency responses
Audit preparation and support
483s and warning letters
Biological safety evaluation

Submissions

510(k)
De novo
FDA electronic medical device reporting
PMA
IDE
Q-sub

过去5年来
We’ve been honored to serve as a CRO partner of choice partner of choice for our medical device and diagnostic customers as we've worked side by side with them to advance their product development.

740+

Global Clinical Device and Diagnostic Studies

3,500

研究中心

147,000

患者

Our team handles the entire clinical process from start to finish including:

Clinical strategy
Clinical study design
Clinical study operations
Site selection and management
Site monitoring services
Database development and management
数据管理
Biostatistics consulting

Medical writing
数据监测委员会(DMC）/数据安全监测委员会（DSMB）管理
临床活动委员会（CEC）管理
Clinical compliance/auditing
Inspection preparedness
Training with the sponsor and sites
临床评估报告(CER)

Enable efficiency across your medical device development.

每项试验都有其独特之处。深思熟虑的试验设计和执行可以最有效地获得有关医疗器材的可靠科学证据。 Combined with optimized study execution, we will deliver the evidence you need for your submission, while saving you time and money during the operational phase of your project.

Our advisors' deep experience can help you to identify ways to improve efficiency and, where possible, reduce your timelines. They will also work with you to pivot your strategy if unexpected findings occur. Let us partner with you from beginning to improve efficiency and speed your time to market.

Understand how we navigate complexities with an integrated approach.

Download our medical device development journey map (PDF)