FROM PATENT TO POST-MARKET
MDx is your trusted partner in MedTech projects, offering comprehensive MD and IVD services from gaining ISO 13485/ISO 15189 quality certification to crafting robust technical documentation for IVDR and MDR. We expertly navigate clinical studies management, vital for achieving CE marking or FDA approval. Collaborating with MedTech companies and their subcontractors, MDx delivers an extensive suite of consultation services for medical devices and IVDs. This includes medical writing, quality assurance, managing clinical investigation and clinical performance studies for diagnostics, and tackling all aspects of MDR and IVDR clinical evidence.
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 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/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
Summarizing the essential data gathered during the design and development of a medical device or IVD product requires robust scientific and technical understanding. The compilation of technical documentation is a regulatory requirement and is key for successful certification.
These documents deliver in-depth information about the medical device, including its design, operations, composition, usage, claims, as well as biological and clinical evaluations and post-market surveillance processes. A technical file, which is a requirement for all device classes (be it Class I, IIa, IIb, and III for medical devices, or A, B, C and D for IVDs), houses all this data. Each technical file is distinct as the information contained therein depends on the classification of the device, its technology and risk-level. Based on your device’s classification, a review by a Notified Body might be required or a Competent Authority may ask for a review of the technical documentation. Understanding how to compile and present this data effectively to Notified Bodies for evaluation is crucial.
Technical and Medical Writing:
- 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 MD and IVD 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.
Medical Devices Consulting Services:
- 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 Consulting Services:
- 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 SERVICES
MDx is a renowned MD and IVD consulting company with deep expertise in MDR and IVDR Quality Assurance, along with the implementation and maintenance of Quality Management Systems (QMS). We aid in pinpointing your QMS needs, followed by our expert team collaborating with you to create, launch, and sustain your QMS. MDx has a proud history of helping numerous clients with the setup and management of their QMS. This involves preparing various stakeholders, including manufacturers and laboratories, for certification audits conducted by Notified Bodies and other accrediting entities. Explore more about our services in quality assurance for IVDs and medical devices:
QMS MD & IVD Consulting Services:
- 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 MD and IVD consulting 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.
MD & IVD Consulting Services:
- MDR Regulatory Affairs
- IVDR Regulatory Affairs
- 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
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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