IVD CRO Services

CLINICAL PERFORMANCE STUDIES

Data accuracy is pivotal for the success of In Vitro Diagnostic (IVD) clinical performance studies. MDx’s clinical affairs team works in tandem with you to guarantee the quality and compliance of collected clinical data, adhering to the clinical performance study plan and other relevant regulations. The ultimate goal is to provide you with reliable, high-grade data for subsequent analysis. The team collaborates closely with you to ensure that the IVD clinical study plan not only meets but also exceeds the expectations of Ethics Committees (EC), adhering to Good Clinical Practice (GCP) guidelines as well as local and international regulations.

MDx ensures strict compliance with Good Clinical Practices (GCP), the EU IVDR 2017/746, and ISO 20916:2019 In vitro Diagnostic Medical Devices – Clinical Performance Studies using specimens for human subjects – Good study practice.

TECHNICAL DOCUMENTATION & MEDICAL WRITING SERVICES

Developing comprehensive technical documentation throughout the design and development stages of an In Vitro Diagnostic (IVD) device requires a deep understanding of both scientific and regulatory nuances. As a specialized IVD CRO, MDx offers a complete range of services aimed at fulfilling regulatory requirements critical for successful device certification.

MDx produces thorough documentation that spans all aspects of the IVD device, from design file and operational protocols to usage guidelines and performance evaluations. This also includes details on analytical testing and post-market surveillance plans.

For every classification of IVD devices—be it Class A, B, C, or D—a technical file is mandatory. MDx tailors each technical file to match the device’s unique classification, technology, and risk management. The company ensures that this vital data is meticulously organized and presented in a format conducive for efficient evaluation by Notified Bodies or Competent Authorities, depending on the device’s classification.

Leveraging extensive experience as an IVD CRO, MDx has the specialized skill set to craft technical documentation that not only complies with all regulatory guidelines but also expedites the approval process.

REGULATORY AFFAIRS FOR IVDs

Navigating the intricate landscape of In Vitro Diagnostics necessitates the expertise of a specialized IVD CRO in regulatory affairs. Partnering with such a specialized entity can substantially improve the effectiveness of compliance efforts. MDx serves as this specialized consultant, well-versed in helping companies meet all regulatory criteria. Whether the goal is to establish the basis for diagnostic equivalence, validate a specific regulatory path, devise a clinical evaluation strategy, or secure market approvals, MDx offers crucial regulatory guidance.

MDx possesses extensive experience in regulatory affairs, aiding IVD manufacturers of all sizes in overcoming the complexities associated with entering the European market. Drawing upon its comprehensive background as an IVD CRO, MDx provides targeted solutions that not only fulfill regulatory requirements but also accelerate the market approval process.

QUALITY ASSURANCE & AUDITING SERVICES

MDx stands as a recognized authority in the In Vitro Diagnostics (IVD) consulting sector, with a specialized emphasis on IVDR Quality Assurance and Quality Management Systems (QMS).

The firm assesses the unique QMS requirements of each client and collaboratively develops, launches, and maintains these systems. With a track record of successfully assisting multiple clients in the management of their QMS, MDx IVD CRO readies key stakeholders—such as diagnostic manufacturers—for audits carried out by Notified Bodies and other accreditation agencies. For a comprehensive overview of MDx’s expertise in quality assurance for IVDs, additional consultation is recommended.

APPROVAL & REGISTRATION

Seeking support for the approval and registration of medical devices?

MDx offers specialized consulting services in IVD 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.

IVD CRO TRAINING

MDx functions as an indispensable training ally in the In Vitro Diagnostics CRO sector. The company’s seasoned professionals collaborate closely with manufacturing units, offering targeted training. This instruction is centered around the calculated planning, organization, and creation of scientific and clinical documents, all with the goal of meeting ambitious project timelines.