Our experienced team can provide the following services:
- Liaise with your EU distributors and ensure they act in a timely manner
- Act as EU coordination centre for medical device customer complaints
- Provide you with details and inform EU competent authorities where appropriate
- Ensure your distributors respond to their complaints in accordance with your instructions
- Inform you within 24 hours when complaints relate to actual or potential patient harm, and discuss best course of action
- If a complaint indicates product recall is advisable or required by the competent authorities, we would proceed with your approval
- It would be our responsibility to inform the competent authorities of nature of incident leading to the recall and obtain their approval before taking action with your distributors
- Coordinate entire medical device product recall process throughout EU member state