Desarrollo de dispositivos médicos

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.

La tecnología innovadora en un dispositivo médico es solo el comienzo. También necesita un plan de desarrollo sólido que pueda ir adaptándose a lo largo del proceso. La evidencia y propuesta de valor convincentes son importantes. Saber priorizar y conocer las diferencias en la definición de valor de las diferentes partes involucradas requieren estrategias creativas y conectadas que maximicen cada etapa de desarrollo. And, as evidence is gathered, it informs and iterates regulatory, reimbursement, clinical and post-market strategies.

Nuestros especialistas en normativa empiezan a trabajar en las primeras etapas para examinar cada aspecto de cumplimiento normativo e identificar posibles problemas que podrían afectar su diseño, materiales, métodos de fabricación o planes financieros. Aprovechamos la experiencia mundial con agencias regulatorias para cultivar estrategias novedosas orientadas a ayudarle a alcanzar aprobación reglamentaria en sus mercados objetivo.

Estrategia

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

Writing

Informes de evaluación clínica (CER, en inglés)
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

En los últimos 5 años
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

Centros de investigación

147.000

Pacientes

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
Gestión de datos
Biostatistics consulting

Medical writing
Comité de monitoreo de datos (DMC)/Gestión de la junta de monitoreo de la seguridad de los datos (DSMB)
Gestión del comité de eventos clínicos (CEC, en inglés)
Clinical compliance/auditing
Inspection preparedness
Training with the sponsor and sites
Informes de evaluación clínica (CER, en inglés)

Enable efficiency across your medical device development.

Cada ensayo tiene características singulares. Un diseño y ejecución de ensayos bien pensados permite lograr la adquisición más efectiva de evidencia científica sólida para su dispositivo. 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)