MedTech Sector comprises of Medical Device Sector, In Vitro Diagnostic Medical Device Sector, and Digital Health Sectors. Among the three, Medical Device Sector is the major stakeholder.
With the turn of the millennium, we have observed an accelerated digital revolution that has demolished boundaries between sectors and resulted in the conversion of technologies. In the meantime, the regulatory body has undergone dramatic changes to catch up with the pace of incoming innovation.
Concurrently, both in our country and globally, healthcare expenditures have skyrocketed, bringing healthcare spending globally under great pressure. Implications of these mega transformations for the MedTech Sector have been immense. These developments have created the need for all stakeholders in our sector to establish new business models.
We aim to collaborate with all MedTech stakeholders in accommodating the big change and offer TB MedTech Consultancy expertise in creating smart solutions.
Transferring experience of more than 40 years to the medical device industry to create sustainable engineering and a circular economy while sustaining integrity in regulatory compliance.
WHAT DO WE DO?
Regulatory Compliance and Certification
Medical Writing and Editing
Quality Management System
Statistical Analysis and Reporting
Regulatory and Quality Management System Consulting & Training
Clinical Evaluation under MDR
Post-Market Surveillance of Medical Devices