Product Expertise
Understanding the science behind your product
Orphan drugs, biologics, or implantable devices present completely different challenges.
Our work is led by product specialists, experienced in bringing to the market the type of
product that our clients are developing.
Medical devices are classified based on associated risks and established mode of action (MOA). Such a classification determines the conformity assessment route and applicable regulatory/clinical/quality requirements.

Within a rapidly evolving regulatory scene, medical devices are under high scrutiny – regulatory requirements are currently being reinforced, in particular to ensure patient safety (clinical evidence, vigilance and market surveillance).

The ongoing transition from a fee-for-service model to a fee-for-value system incentivizes outcomes over technological inputs, and requires an increasingly sound demonstration of clinical and economic value to health care systems.

Key challenges encompass:

  • Product qualification/classification
  • Market clearance routes
  • Indications for use
  • Safety & Performance claims
  • Risks analysis and risk management plan
  • Biocompatibility and clinical evidence demonstration
  • Vigilance and Post-Market Surveillance (PMS)
  • Quality Management System (QMS)
  • Market access strategy and value demonstration to payers