Wainwright Associates can assist with the setup and operation of your medical device vigilance procedures.
As of January 2008 new EU guidelines on the Medical Device Vigilance System came into effect in order to facilitate a uniform application of the requirements described in the EU Medical Device Directives.
Wainwright Associates can review your existing vigilance procedures and advise on appropriateness with respect to compliance with the MEDDEV Guidelines.
Alternatively we can assist with the development and implementation of an appropriate vigilance system. This may range from advice as to what procedures are required to generation of written procedures themselves to be held as part of your technical file. Documents can be prepared either in our own house style or according to the client's template, as required.
In addition we can undertake to carry out day-to-day device vigilance activities on your behalf if required. This may include:
- documentation and further investigation of any reported incidents;
- assessment and notification to Competent Authorities on your behalf where required;
- generation of Field Safety Corrective Actions where required;
- generation and distribution of Field Safety Notices;
follow-up with the Competent Authorities as required.