Complaints Handling ISO 13485

Jeevan

Registered
Hi, I am working in a medical device company and looking for the improvements in complaints complaint handling process. We follow ISO 13485, MDSAp , EU MDR and other applicable regulations. Can some one please share their complaint handling process SOP, FOrms used. Do you assess all complaints in the system? How do you classify complaints?
 

ChrisM

Quite Involved in Discussions
If you search the internet you will come across the generally accepted definition of a complaint as "any written, electronic, or oral communication that alleges deficiencies in a medical device's identity, quality, durability, reliability, usability, or safety or performance".
Sharing a process is difficult as I'm not sure ow to upload anything here, no longer work in a Medical Device environment plus we all do things in different ways. All complaints must be recorded and initially assessed in a very tight timeframe to determine if they are reportable. You therefore need a team of people on call at all times to receive notification of a complaint to make this assessment, and this team must also have to hand the method to report the complaint if it is reportable, within the required timescale. Previously where I worked this meant that a handful of us had to have access to our work emails on a mobile device no matter where we were, and there were 2 members of staff permanently on standby (out of working hours) for the reporting aspects. This included weekends and public holidays, and when away on vacations etc
 

Tidge

Trusted Information Resource
All complaints must be recorded and initially assessed in a very tight timeframe to determine if they are reportable. You therefore need a team of people on call at all times to receive notification of a complaint to make this assessment, and this team must also have to hand the method to report the complaint if it is reportable, within the required timescale.
/agree

Hi, I am working in a medical device company and looking for the improvements in complaints complaint handling process. We follow ISO 13485, MDSAp , EU MDR and other applicable regulations. Can some one please share their complaint handling process SOP, FOrms used. Do you assess all complaints in the system? How do you classify complaints?

I find it difficult to believe that it is possible to "follow MDSAP" and NOT have an established complaint-reporting process. I may have some tunnel vision as our complaint-reporting process is decades-old from reporting complaints to the FDA. The only 'sharp edge' in the area of complaint-reporting we have encountered with MDSAP audits has been related to an extremely small number (i.e. one complaint) of on-time reporting for other countries in very specific circumstances. The circumstance for us was related to a complaint that was assessed to be non-reportable, standard diligence followup conversations revealed it to be reportable within FDA required timelines but the international date line got us!
 

Jeevan

Registered
If you search the internet you will come across the generally accepted definition of a complaint as "any written, electronic, or oral communication that alleges deficiencies in a medical device's identity, quality, durability, reliability, usability, or safety or performance".
Sharing a process is difficult as I'm not sure ow to upload anything here, no longer work in a Medical Device environment plus we all do things in different ways. All complaints must be recorded and initially assessed in a very tight timeframe to determine if they are reportable. You therefore need a team of people on call at all times to receive notification of a complaint to make this assessment, and this team must also have to hand the method to report the complaint if it is reportable, within the required timescale. Previously where I worked this meant that a handful of us had to have access to our work emails on a mobile device no matter where we were, and there were 2 members of staff permanently on standby (out of working hours) for the reporting aspects. This included weekends and public holidays, and when away on vacations etc
Thanks Chris.
 
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