Entwicklung medizinischer Geräte

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.

Innovative Technologie für ein medizinisches Gerät ist erst der Anfang. Sie brauchen auch einen soliden Entwicklungsplan, der im Laufe der Zeit angepasst werden kann. Es kommt auf aussagekräftige Belege und ein überzeugendes Wertversprechen an. Konkurrierende Prioritäten und unterschiedliche Stakeholder-Definitionen von Wert erfordern kreative, zusammenhängende Strategien, die jede Entwicklungsstufe maximieren. And, as evidence is gathered, it informs and iterates regulatory, reimbursement, clinical and post-market strategies.

Unsere behördlichen Spezialisten fangen früh an und untersuchen jeden Aspekt der behördlichen Compliance, um potenzielle Probleme zu identifizieren, die sich auf Ihr Design, Ihre Materialien, Ihre Herstellungsmethoden oder Ihre finanziellen Pläne auswirken könnten. Wir nutzen unsere weltweite Erfahrung mit Behörden und kultivieren neuartige, zielgerichtete Strategien, die Ihnen helfen, die Zulassung in Ihren Zielmärkten zu erreichen.

Strategie

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

Writing

Klinische Bewertungsberichte (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

Die vergangenen 5 Jahre
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

Wissenschaftsstandorte

147.000

Patienten

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
Datenmanagement
Biostatistics consulting

Medical writing
Management des Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB)
Management des Clinical Events Committee (CEC)
Clinical compliance/auditing
Inspection preparedness
Training with the sponsor and sites
Klinische Bewertungsberichte (CER)

Enable efficiency across your medical device development.

Jede Studie hat einzigartige Merkmale. Durch eine durchdachte Studienplanung und -durchführung wird die effizienteste Gewinnung fundierter wissenschaftlicher Beweise für Ihr Gerät erreicht. 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)