Clinical evidence is vital for medical products
Due to the growing complexity and innovation of the medical device industry a new legislation has to be met, the Medical Device Regulation. The MDR was published in May 2017 and will fully apply in May 2021.
Is your company MDR ready? It is fundamental that you can continue to deliver high quality products and services to clients and patients. Therefore, not meeting the deadline of May 2021 is not an option. Clinical evidence of safety and performance will be inevitable for your products as there will be enhanced vigilance and market surveillance.
Are you in need of collecting key clinical data to comply with the new regulation? Let our motivated team of research professionals assist you in every step of your clinical trial.
As a full-service medical device Contract Research Organization (CRO), Archer Research offers consultancy, regulatory, and clinical trial services as well as data management, biostatistics and medical writing. We aim to successfully deliver valuable clinical data for investigational devices to meet the medical needs for the patient and to continuously monitor the quality and safety of the device during the device lifecycle.
So if you need help in conducting medical device clinical studies in Europe, do not hesitate to inform yourself at Archer Research.
We are more than happy to help you with your questions and possible gaps in your clinical evidence. Do not hesitate to reach out via contact info below:
info@archerresearch.eu +32 11 28 69 35