IVDEXEL

IVDEXEL, based in the Australia, is a consulting company that specializes in providing regulatory, quality assurance, and post-market surveillance support in the Medical Device and In Vitro Diagnostics (IVD) fields. They help clients navigate complex regulatory landscapes, such as the MDR/IVDR for CE Marking and ISO standards including ISO 13485 for quality management systems and ISO 14971 for risk management. Their services are designed to ensure that medical devices and IVDs meet the stringent requirements set by various regulatory bodies.

Services Offered Include:

• Quality management system implementation and maintenance
• Risk management according to ISO 14971
• Regulatory consulting for MDR/IVDR compliance and CE Marking
• Technical documentation preparation and Notified Body submissions
• Training on new regulations and their impact on products

Regions Served:

• Primarily the Australia focusing on manufacturers and distributors of medical devices and IVDs needing regulatory compliance and quality assurance.

See edits to this page? Please submit any corrections here.