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
