Services
MedTech commercialization process involves many challenges pertaining to Research & Development, establishing a Quality Management System (QMS), developing a Regulatory Strategy and Performing Clinical Validation. 8C Healthcare works with global MedTech manufacturers to overcome their challenges by
- Enabling Iterative Clinical Development to mitigate device failures and achieve clinical success
- Helping in establishing a QMS in compliance to the regulatory requirements
- Developing a regulatory strategy and obtaining regulatory clearances/approvals.
- Providing required trainings on harmonized standards and regulations
