FROM PATENT TO POST-MARKET
MDx provides the expertise to set up and manage MedTech projects, from quality assurance support with the ISO 13485/15189 certification to IVDR/MDR technical documentation development, as well as the design and management of clinical studies for CE marking or FDA approval. MDx partners with the MedTech industry and their subcontractors to provide a wide range of medical device and IVD consulting services, including medical writing services, quality assurance for medical devices, clinical investigation and clinical performance studies, as well as all aspects of IVDR performance evaluation.
CLINICAL RESEARCH
The accuracy of the data gathered is critical to the success of the medical device clinical investigation and IVD clinical performance studies. The clinical affairs team at MDx collaborates with you to ensure that clinical trial 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/IVDR, and ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects, as well as ISO 20916:2019 Clinical Performance Studies using human subject specimens for in-vitro diagnostic devices. MDx can be involved in all or part of your clinical operations, depending on your budget and the availability of in-house specialists.
Services provided:
- Clinical Strategy.
- Study design and protocol development.
- Clinical document creation and management.
- Ethics Committee and Competent Authority Submission in the EU.
- Clinical Investigation monitoring
- Clinical Investigation Postmarket study design and management.
- Paper or EDC data collection capability.
- Clinical database development, entry, processing, querying, maintenance, and reporting.
- Training for clinical study staff and site-level staff.
- Creation of study progress reports.
- Clinical Events Committee/Data Safety Monitoring Board support network.
- Clinical Quality.
TECHNICAL DOCUMENTATION & MEDICAL WRITING SERVICES
To accurately summarize the essential data acquired during the development of a medical device product, regulatory papers necessitate strong scientific and technical knowledge.
The technical documents contain extensive information such as the medical device’s design, operation, composition, usage, claims, biological and clinical assessment and the post-market surveillance process. A technical file is necessary for all device classes (Class I, IIa, IIb, and III), however no two technical files are the exact since the information contained in the technical file is determined by the device classification. Depending on your device classification, a Notified Body is required to examine the technical documentation or a Competent Authority may request the technical package review. It is critical to understand how to develop and compile this data and present it to Notified Bodies for review.
Services provided:
- Labeling and Instructions For Use (IFU)
- General Safety and Performance Requirements (GSPR)
- Risk Management Plan and Report (RMP and RMR)
- Clinical Evaluation Plan and Report (CEP and CER)
- Performance Evaluation Plan and Report (PEP and PER)
- Post-Market Surveillance Plan (PMSP)
- Post-Market Clinical Follow Up Plan (PMCFP)
- Summary of Safety and Clinical Performance (SSCP)
- Periodic Safety Update Reports (PSUR)
REGULATORY AFFAIRS
As the medical device ecosystem becomes more sophisticated, collaborating with a company specialized in regulatory affairs for medical devices and diagnostics can have a big impact on your compliance efforts. A skilled regulatory consulting firm can assist you in your effort to meet all regulatory requirements, whether your objective is to develop the rationale for the equivalence of your medical device, confirm your regulatory pathway and your clinical evaluation strategy, or prepare for and obtain market approvals. MDx experts have significant expertise in providing regulatory guidance to medical device manufacturers of all sizes looking to introduce their products to European. MDx experts have assisted with the launch of more than 120 new medical devices.
Medical Devices:
- Medical device classification.
- MedTech Roadmap: From patent to the market (EU MDR).
- CE Mark Strategy.
- Technical File Development and Compilation for Class I, II, and III.
- UDI consulting.
- ISO 14971 risk management consulting for medical device companies.
- Post Market Clinical Follow Up (PMCF).
In Vitro Diagnostic:
- In Vitro Diagnostic Classification.
- EU IVDR Roadmap: From patent to the market (EU IVDR).
- EU IVDR Technical Documentation Development.
- UDI consulting.
- ISO 14971 risk management consulting for in-vitro diagnostics companies.
- Post Market Performance Follow Up (PMPF).
QUALITY ASSURANCE & AUDITING
MDx is a consulting and outsourcing firm that specializes in MDR and IVDR Quality Assurance related to Quality Management Systems (QMS). We assist you in determining when you require a QMS, and then our specialists collaborate with you to build, deploy, and maintain your QMS. MDx has assisted more than 20 clients with the installation and management of their QMS, including our involvement in the auditing of the QMS by Notified Bodies. Learn more about our services in quality assurance for IVDs and medical devices:
Services provided:
- MDR Quality Assurance Consulting
- IVDR Quality Assurance Consulting
- QMS development and implementation for large multinational enterprises.
- QMS development and implementation for MedTech Start-up companies.
- QMS administration and management.
- QMS ISO 13485 procedures for Software as a Medical Device (SaMD) companies.
- QMS ISO 13485 procedures for Medical Device manufacturers.
- QMS ISO 13485 procedures for In-Vitro Diagnostics (IVD) manufacturers.
- QMS ISO 15189:2012 for Medical Laboratories.
- QMS ISO/IEC 17025 laboratory accreditation
- GDPR procedures for medical device companies and medical software.
- Transition from ISO 13485:2003 to ISO 13485:2016.
- Audits to ISO 13485, 21 CFR Part 820, MDD/MDR and other applicable regulations for medical device companies.
- QA and RA due diligence audits of medical device companies.
- Quality assurance outsourcing.
- Interim Management.
- Spreadsheet Validation.
APPROVAL & REGISTRATION
Do you require assistance with the approval and registration of your medical devices?
As a part of our medical device and IVD consulting services, MDx can assist you in obtaining medical device approval in Europe and the US. Our medical device registration experts in these areas have strong knowledge of the CE Mark and FDA process, and relationships with the MedTech ecosystem to complete your registration as quickly as possible to achieve medical device approval.
The European Regulations:
- CE Mark approval for Medical Devices
- CE Mark approval for In Vitro Diagnostic (IVD)
- Manufacturer and Importer license
- Local device registration
- Notified Body and Competent Authorities communications
- EUDAMED registration
TRAINING
MDx is also your training partner. MDx experts can work as essential members of the manufacturers, training them how to strategically design, coordinate, and develop their clinical and scientific documentation to achieve competitive timeframes.
Services Provided:
- ISO 13485:2016
- ISO 14971:2019 Application of risk management
- ISO 14155:2020
- ISO 15189 QMS for Clinical Laboratories
- ISO 20916 IVD medical devices-Clinical performance studies for human subjects
- EU MDR 2017/745
- EU IVDR 2017/746
MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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