Services
Global Regulatory Solutions
MDRA is a dedicated consultancy firm with team of highly qualified and experienced Regulatory Affairs professionals. By leveraging our extensive regulatory affairs experience and scientific knowledge, we aim to deliver comprehensive regulatory strategies that facilitate successful product launches and long-term market success.
We work with MedTech manufacturers to develop and execute innovative regulatory strategies from early product development to post-licensing activities for Medical Devices, IVD, Combination Devices and Digital Health (AI).
Our regulatory strategies are designed to be proactive and adaptable, allowing our clients to remain competitive in an ever-changing market.
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Our Services
In-Country Representation (Authorised Representative)
MDRA acts as a single point of representation for your devices globally.
Regulatory Affairs & Market Access
MDRA guides you through the process of device approval from the stage of concept to fully approved device on the global market.
Quality Management System (QMS) for Medical Devices & IVD
Clinical Evaluation (CEP&CER) for Medical Devices
Performance Evaluation (PEP&PER) for IVD
Biological Evaluation (BEP&BER)
Sterilization & Microbiology
