Med-IVD Tech

logo MED IVD HEALTTECH

Contact information

Med-IVD Tech
David Tomé, Senior Consultant of Medtech Operations
Calle Baltasar Gracian S/N
Torrecaballeros
Segovia
+34 616761956
Areas of activities
  • A. Health Biotechnology
    • Areas of activity
      • Biomarkers
      • Cell cultures and mantenance
      • In vitro diagnostics
      • Diagnostic imaging
      • Medical devices
      • Drug delivery
      • Screening
      • Biomaterials and tissue therapy
      • Transplant
    • Therapeutic areas
      • Substance abuse
      • Analgesia & Pain
      • Dermatology
      • Musculoskeletal system
      • Cardiovascular diseases and circulatory system
      • Genetic and rare diseases
      • Infectious diseases
      • Inflammatory diseases
      • Gynaecology and obstetrics
      • Immunology
      • Odontology
      • Ophtalmology and optometry
      • Oncology
      • Blood and lymphatic system
      • Kidney and genitourinary system
      • Central nervous system
      • Respiratory and pulmonary system
      • Metabolic disorders / Endocrinology
  • D. Services
    • R&D services
      • CRO / CMO / SMO
    • Professional services
      • Consultancy
      • Training and spreading

Med-IVD Tech is the expert consulting firm for Regulatory Affairs, Clinical Research, and Quality Assurance for the MedTech and IVD industries

Med-IVD Tech offers complete life-cycle expert support for your medical device and in-vitro diagnostic projects. 

Their expert team designs an optimal plan for your CE Mark and FDA strategy for saving time and resources in your medical device innovation pipeline.
 

Products and services

The service are established in three categories:

  • Regulatory Affairs: The Regulatory Affairs consulting services cover from the intended purpose definition to technical file development and other key points such as the Risk Management and the Clinical Evaluation. 
  • Clinical Research: The Clinical Research expert and strategist support provide the design and development of clinical investigations and performance studies. 
  • Quality Assurance: The Quality Assurance consulting services provide design, implementation, and management of the Quality Management Systems following several standards for healthcare companies.
     
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Areas of interest for future collaborations
  • Interest areas for futures colaborations/alliances, etc    - In Vitro Diagnostics (IVD)
  • Medical Device / Medical Device
  • Next-Generation Sequencing NGS
  • Software as Medical Device
  • Software as IVD
  • Coronary Stents
  • Companion diagnostic CDx
  • Implantology and Digital Dentistry
  • Ophthalmology
  • Artificial Intelligence
  • ISO 13485:2016
  • 21 CFR Part 820
  • ISO 14971:2019
  • ISO 14155:2020
  • ISO 20916:2019
  • ISO 15189
  • IEC 62304
  • IEC 82304