MDT provides the expertise to set up and manage MedTech projects, from ISO 13485/15189 certification to IVDR/MDR technical file development, as well as the design and management of clinical studies for CE Marking or FDA approval.
The accuracy of the data gathered is critical to the success of a medical device clinical study. The clinical affairs team at MDT 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. Our clinical affairs team will collaborate closely with you to ensure that the clinical investigation plan accurately represents you to Ethics Committees (EC) and complies with Good Clinical Practice (GCP) guidelines as well as the local regulations.
MDT 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 – In-vitro Diagnostic Medical Devices. – Clinical performance studies using human subject specimens – Good research practice MDT can be involved in all or part of your clinical investigation operations, depending on your budget and the availability of in-house specialists.
MDT is a consulting and outsourcing firm that specializes in Quality Management Systems (QMS) for the medical device sector. We assist you in determining when you require a QMS, and then our specialists collaborate with you to build, deploy, and maintain your QMS. MDT 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.
MDT 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.
As the medical device ecosystem becomes more sophisticated, collaborating with an experienced regulatory advice firm can mone 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. MDT experts have significant expertise in providing regulatory guidance to medical device manufacturers of all sizes looking to introduce their products to European. MDT experts have assisted with the launch of more than 120 new medical devices.
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.
MDT is also your training partner. MDT 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.
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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