Client Background:
The manufacturer produces suction Cather which belongs to Class IIa and are suitable for clearing the airway in patients. It is intended for removing secretions from mouth/ pharynx/trachea/bronchial tubes in critically ill patients with a weakened ability to spontaneously clear secretions/debris.
Client Problem:
Medical device belonged to Class IIa and needed CE certificate from European Medicines Agency (EMA) to sale and distribute in EU.
ND Global Solution & Approach:
ND Global developed a document template for the CE certificate per the EU-MDR 2017/745. The customer received thorough support to prepare their file for the CE certificate.
Project Achievements:
Based on their positive experience, the customer extended the scope of work to seek support for other devices.
Project Outcomes:
The device received a CE certificate after the EMA reviewed and accepted it without making any observations.