Services

Quality Management System

US FDA Premarket Notification and Premarket Approval

European Medical Device Regulation

• Establishment of Quality Management System in line with FDA 21 CFR 820, ISO 13485:2016. ISO 9001: 2015. 
• Gap analysis among quality system against requirements.
• Training and awareness on the implementation of the components of quality management system.
• Perform 2nd party audits.

European Medical Device Regulation

US FDA Premarket Notification and Premarket Approval

European Medical Device Regulation

• Establishment of Technical Documentation in compliance with MDR (EU) 2017/745.
• Assistance on maintaining Medical Device Directive Requirements.
• Training on components of technical compliance such as Risk Management, Post Market Surveillance, Unique Device Identification, Medical Device Reporting, Corrective and Preventive Actions.

US FDA Premarket Notification and Premarket Approval

US FDA Premarket Notification and Premarket Approval

US FDA Premarket Notification and Premarket Approval

• Assisting entrepreneurs get their first product to market in the USA or Canada.