Medical Device CRO Services

CLINICAL INVESTIGATIONS

The accuracy of the data gathered is critical to the success of the medical device clinical investigations. The clinical affairs team at MDx collaborates with you to ensure that clinical study data is gathered, input, cleaned, and reported in compliance with the protocol and other regulations. The end aim is to offer you high-quality, dependable data for analysis. The clinical affairs team will collaborate closely with you to ensure that the medical device clinical investigation plan accurately represents you to Ethics Committees (EC) and complies with Good Clinical Practice (GCP) guidelines as well as local regulations.

MDx ensures adherence to Good Clinical Practices (GCP), the European Clinical Trial Regulation (No 536/2014), the MDR, and ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects. MDx can be involved in all or part of your clinical operations, depending on your budget and the availability of in-house specialists.

TECHNICAL DOCUMENTATION & MEDICAL WRITING SERVICES

Creating detailed technical documentation during the design and development phases of a medical device is a task that demands robust scientific and technical expertise. In the role of a specialized medical device CRO, MDx offers a comprehensive set of services that meet both regulatory obligations and are pivotal for obtaining successful device certifications.

MDx provides exhaustive documentation that covers every facet of the medical device, from design schematics and operating procedures to guidelines for use and clinical evaluations. This also encompasses information on biological assessments and post-market monitoring protocols.

For all categories of medical devices—be it Class I, IIa, IIb, III— a technical file is obligatory. Each technical file compiled by MDx is customized according to the device’s specific class, underlying technology, and associated risk levels. MDx ensures that this critical data is methodically arranged and presented in a manner that facilitates effective scrutiny by Notified Bodies or Competent Authorities, depending on the device’s classification.

With its extensive experience as a medical device CRO, MDx possesses the specialized skills required to prepare technical documentation that not only adheres to all regulatory guidelines but also streamlines the approval process.

REGULATORY AFFAIRS

The landscape of medical devices is increasingly complex, making it vital to engage with a specialized firm in regulatory affairs for medical devices. Partnering with such experts can significantly enhance the efficacy of compliance initiatives. MDx serves as this expert entity, proficient in aiding companies to fulfill all regulatory demands. Whether the focus is on establishing the grounds for device equivalence, validating a regulatory pathway, crafting a clinical evaluation strategy, or facilitating market approvals, MDx provides invaluable regulatory guidance.

MDx brings to the table a wealth of expertise in regulatory affairs, supporting medical device manufacturers of varying sizes in navigating the complexities of European market entry. With its comprehensive background as a medical device CRO, MDx offers targeted solutions that not only ensure regulatory compliance but also expedite the market approval process.

QUALITY ASSURANCE & AUDITING SERVICES

MDx is a recognized leader in the Medical Device consulting space, with specialized focus on MDR Quality Assurance and Quality Management Systems (QMS).

The firm identifies client-specific QMS needs and collaborates to develop, implement, and maintain these systems. With a history of successfully aiding numerous clients in managing their QMS, MDx prepares key stakeholders, such as manufacturers, for audits conducted by Notified Bodies and other certification organizations. For a thorough understanding of MDx’s capabilities in quality assurance for medical devices, further inquiry is advised.

APPROVAL & REGISTRATION

Seeking support for the approval and registration of medical devices?

MDx offers specialized consulting services in medical device approvals, catering to both European and U.S. markets. With a team of experts well-versed in CE Mark and FDA processes, MDx leverages its network within the MedTech ecosystem to expedite registration procedures. The aim is to secure medical device approval as efficiently as possible for clients.

MEDICAL DEVICE CRO TRAINING

MDx serves as a vital training partner in the MD consulting landscape. The firm’s experts integrate seamlessly with manufacturing teams to provide specialized training. This guidance focuses on the strategic design, coordination, and development of clinical and scientific documentation, all aimed at achieving competitive timeframes for project completion.