Mediteq hosted an event focused on PMS and PMCF activities at the Mediteq Forum.

Meditea guides you in regulatory requirements, market access and CE-marking of medical devices. Our expertise covers all areas of medical technology, from evidence strategy and regulatory plans, to review by Notified Body (NB) or authority. And also technical documentation for complex products with high patient risk, and management systems for start-ups and international enterprises. We help our customers with: Tasks within operational services: Complaint or deviation management Compile, submit and maintain product registrations Update routines and documents in the management systems Collection and compilation of postmarket data Update and review of risk management process and files Literature search for clinical or biological evaluation Questions we help our customers with: Is this a medical device or an in-vitro diagnostic product? What is needed to get it CE-marked or approved by the FDA? What approvals are required in the EU or the US? Management system – Is it a requirement? Does it have to be certified? Clinical trial – Is it necessary? How much clinical data is needed for my product? Risk management – How is it done? And can it be simplified? Data management – Is GDPR or another regulation applicable? Mediteq supports small and large customers in industry, academia and healthcare sector to understand and comply with regulatory requirements for medical devices in a clear, easy and effective way by delivering knowledge and results in the Mediteq Forum knowledge network, training and consulting services. Mediteq is a personal, professional and customer-oriented consulting company with clear targets, innovative thinking and long-term perspectives in our assignments. Mediteq’s consultants work together under individual freedom and responsibility to dynamically manage expectations with structure, communication and presence, thereby creating long-term results and relationships.