In a world of increasing healthcare expenses, the need for safe and effective medical device technology is greater than ever. All stakeholders, including patients, regulators and manufacturers, benefit from innovation and access to the most effective solutions for clinical needs. Ensuring that all new technology meets regulatory requirements is critical and absolutely expected for all new devices.
Setting incorrect expectations in the regulatory clearance process, such as CE Marking for the European market, can lead to delays that have far reaching consequences for all stakeholders.Incorrect expectations can:
- Hold up benefits to patients, clinicians, healthcare providers and payers
- Restrict the access to the most effective technologiesImpact investment needed to achieve commercialization of new devices
- Damage confidence in manufacturers
- Disappoint stakeholders requirements