Device vigilance for health technology

Do you need support with safety related activities for your medical devices and in vitro diagnostic medical devices? DRA can do all the hard, detailed work for you. We have the skill and capacity to handle a range of post-market surveillance (PMS) activities, including product complaints, for your company. Our device vigilance services give you peace of mind – we will respond immediately if any incidents are identified.​

Our device vigilance services for MD and IVD devices include:

  • PMS plans and reports​ including data collection and data analysis​
  • Receiving, assessing and reporting incident reports​
  • Field Safety Corrective Actions (FSCA) and Notices, plans and reports​
  • Preparation of Periodic Safety Update Reports (PSUR)​
  • Device vigilance training​
  • The whole product quality complaints procedure​ including translations

DRA offers support with device vigilance for your medical devices and in vitro diagnostic medical devices. We can manage all the day-to-day device vigilance activities and we will respond immediately if any incidents are reportable to Competent Authorities. Our specialist team has the capacity and the expertise needed to ensure compliance with the latest regulations.​ ​

​Continuously monitoring and analysing literature and submitting regular reports is time consuming and takes a dedicated team of experts. Post-market surveillance of all classes of MD and IVD devices also requires device vigilance and Field Safety Corrective Actions (FSCA). Whenever FSCA actions are needed, the changes may affect the whole supply chain from the manufacturing site all the way to the patient. This means that proper processes must be in place and that communications to all stakeholders must be clear and complete. DRA may support on your company on every stage, including notifying the authorities.​