Strategy Support

Stage-Based Strategy Support for Medical Device Development

For innovators with early prototypes, proof-of-concept data, or preclinical medical devices, we define the most efficient regulatory and evidence-generation path toward first-in-human readiness:

  • Regulatory medical device classification and CE-mark roadmap (MDR/IVDR)

  • Preclinical requirements: bench testing, usability and animal studies

  • Readiness assessment for first-in-human or early feasibility studies

  • Early identification of evidence gaps impacting approval or reimbursement

Scientist handling a medical device connected to a monitor with a waveform display, with purple gloves, in a laboratory setting.

Early Development & Preclinical Strategy

For medical devices approaching clinical investigation, we design regulatory-aligned clinical and evidence-generation strategies supporting approval and post-market requirements.

  • Selection of the appropriate clinical development approach (feasibility, pivotal)

  • Clinical investigation design aligned with MDR and ISO 14155

  • Preparation of regulatory submissions and essential study documents

  • Clinical evidence generation supporting approval and post-market clinical follow-up (PMCF)

  • Early PMCF strategy definition to avoid late-stage redesign

Medical professional holding a tablet displaying patient vital signs, with a patient lying in a hospital bed connected to monitoring equipment.

Clinical Investigations & Evidence Generation Strategy

For CE-marked or FDA-cleared medical devices, we support post-approval growth through regulatory, clinical, and evidence strategies aligned with market access planning and long-term lifecycle objectives.

  • Regulatory and geographic expansion strategy planning

  • Alignment of post-market clinical follow-up requirements

  • Real-world evidence data collection

  • Strategies supporting reimbursement discussions

  • Long-term lifecycle planning beyond initial approval

Stack of papers on a desk with a world map, office supplies, and a digital overlay of graphs and icons, labeled 'Regulatory' and 'Post-Market'.

Market Access, Expansion & Lifecycle Strategy

Not Sure About Your Development Stage?

Many medical device and IVD manufacturers face uncertainty when positioning their product within the regulatory and clinical development landscape. Iberania provides early strategic assessment and clarification to identify your current development stage, critical evidence gaps, and the most efficient next steps toward compliant market access.

Request a Strategic Assessment