Clinical Evaluation

The Medical Device Regulations (MDR) entered into force in May 2017.  Manufacturers need to demonstrate that their medical devices meet the stated requirements by carrying out a conformity assessment. The Clinical Trials Consultancy will enable you to determine if a Clinical Investigation (trial) is necessary for your medical device to pass this assessment and, if so, assist with:

  • Clinical Evaluations
  • Which medical devices need a Clinical Investigation
  • Costings and timelines
  • Clinical Investigation planning and design
  • Regulatory approval from Competent Authority/Ethical Committee
  • Protocol required procedures
  • Investigations and tasks in line with the MDR