The global medical device market is expanding, driven by a growing need for advanced healthcare solutions. However, navigating the complex regulatory landscape and conducting successful clinical trials is crucial for bringing these life-saving innovations to patients. Palleos, a full-service CRO specializing in medical devices, offers comprehensive solutions to streamline this process.
At Palleos, meticulous attention to detail is paramount at each stage of the medical device journey. We carefully select and coordinate with the most appropriate accredited testing facilities. Our team prepares all documentation needed for testing and registration. Palleos also manages all sample import logistics and thoroughly reviews all expert opinions, ensuring all documentation is finalized accurately.
Palleos understands that well-executed testings are the cornerstone of medical device approval. Our team of experienced professionals designs and executes comprehensive tests for your Medical Devices, providing a seamless and efficient process from initial strategy development and documentation preparation to rigorous data analysis and detailed reporting. We adhere to the highest ethical and regulatory standards to ensure your tests meet the demanding requirements of authorities.
Palleos provides comprehensive medical device testing services, including technical, toxicological, and clinical testing, customized to meet the specific requirements of each device class and sponsor. The company also facilitates the import of medical devices.
Gaining market access in the Central and Eastern Europe (CEE) region requires meticulous attention to local regulations. Palleos provides comprehensive support for the medical device registration process, ensuring your product meets the specific requirements for market access in your target regions. We understand the complexities of the regulatory landscape and provide expert guidance to ensure a smooth and efficient pathway for market authorization.
Palleos’s key marketing authorization services include dossier audit and amendment, post-market changes to registration certificates and dossiers, and medical device marketing authorization.
The timelines and costs associated with testing and registration are influenced by factors such as the class of a particular medical device, the completeness of documentation provided by sponsor, the specific tests required, the number of samples needed, and more. To ensure complete transparency, our detailed project budgets consist of approximately 400 individual line items, providing a clear breakdown of all costs. Palleos provides transparent pricing and realistic deadlines.
Ready to bring your innovative medical device to patients in Europe? Palleos is committed to helping its sponsors succeed. Reach out to the team of experts for a free consultation to discuss your specific needs and explore how Palleos can navigate you through every stage of the process. Reach out to our team at info@palleos.com
