WHAT IS A MEDTECH CRO?

A MedTech CRO is a company that provides contract research organization services to aid medical device manufacturers in the entire process, from patent to post-market support. It provides quality assurance, medical device regulatory affairs, and clinical investigation expertise to be the optimal partner for the development of medical technologies.

WHAT IS AN IVD CRO?

An IVD CRO is a contract research organization that specializes in supporting IVD manufacturers and laboratories from the In-Vitro Diagnostics patent to the post-market phase. An IVD CRO provides quality assurance and regulatory and clinical performance expertise to be the optimal partner for the development of in-vitro diagnostics technologies and in-house testing.

OUR MEDTECH-IVD CRO

As a Medical Device CRO in Europe, MDx offers complete life-cycle expert support for your medical device and in-vitro diagnostic projects. The expert team designs an optimal plan for your CE Mark strategy to save time and resources in your medical device and IVD innovation pipeline. Covering the development of Technical Documentation, medical writing for Clinical Evaluation and IVD Performance Evaluation and the Clinical Research Operations management under the EU MDR 2017/745 and EU IVDR 2017/746.

MEDTECH CRO SERVICES

THE IMPACT OF THE EU MDR AND EU IVDR ON THE IMPLEMENTATION OF MEDICAL TECHNOLOGIES IN EUROPE

EU MDR 2017/745 and EU IVDR 2017/746 entered into force on May 26, 2021 and 2022, respectively. For the MedTech manufacturers, the new European regulations represent an expansion of the scope to include more products, a global convergence of other European and international regulations, a risk-based reclassification, stricter clinical evidence requirements, increased scrutiny and involvement of Notified Bodies, a greater emphasis on Post-market surveillance, and new requirements for the medical devices and in vitro diagnostics manufacturers’ quality management systems (QMS).

TEAM CREDENTIALS

THE DIFFERENCE BETWEEN CLINICAL TRIALS, CLINICAL INVESTIGATIONS AND CLINICAL PERFORMANCE STUDIES

• EU MDR 2017/745 defines clinical investigation as a systematic study involving human subjects to evaluate the safety or performance of a medical device;
• EU IVDR 2017/746 defines clinical performance study as a study done to establish or confirm the clinical performance of a device, which is the ability of a device to produce results that are related to a particular clinical condition, physiological or pathological process or state, and the target population and intended user;
• ICH E6 defines clinical trial as an investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

MEDTECH CRO PRODUCT AREAS