Safety Management & Vigilance

TRIQ provides you with the full Medical Device Vigilance & Safety Services or customer made single service packages according to your needs. TRIQ has experience in managing Medical Device Vigilance processes for small and medium sized medical device companies and can help you to be compliant according to EU 2017/745 MDR and all applicable regulations.

Medical Device Safety

We support our customers to be compliant related to all safety aspects of their Medical Device. We provide accurate review, documentation, collection and follow -ups of Adverse Events (AEs),  Serious Adverse Events (SAEs), Serious Adverse Device Event (SADEs) and Device Deficiencies (DDs). The safety reporting to the Competent Authority and the Sponsor is guaranteed to be on time.

Safety Management & Vigilance Reporting

TRIQ Services includes the following:

• Safety review and revision of the Clinical Investigation Plan and applicable trial documents
• Creation of the Safety Management Plan and safety related documents
• Management and assessment of Adverse Event (AE),  Serious Adverse Event (SAE),  Serious Adverse Device Events (SADE) & Device Deficiencies (DD)
• Reporting to Competent Authorities, Ethics Committees, if applicable and  Investigators
• Medical Review and Assessment of Seriousness and Causality
• Literature Surveillance
• Preparation of Annual Safety Reports
• And much more