This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.
I doubt many people have the knowledge to to truly troubleshoot our devices beyond what the doctor is allowed to do. We need a bunch of expensive and specialized hardware to troubleshoot.
If a certain number(honestly I don’t know the specific number) of complaints occur we are legally required to create a corrective action to help the patients immediately (or as soon as possible) and a preventive action to ensure it doesn’t effect other patients. If a person has an issue and “repaired” it themselves they don’t get counted in this and as such could cause more patients to suffer.
While I agree with right to repair I think certain things should be exempt. That said then there should be a requirement of the manufacturer to ivestigate/repair the equipment.
This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.
I doubt many people have the knowledge to to truly troubleshoot our devices beyond what the doctor is allowed to do. We need a bunch of expensive and specialized hardware to troubleshoot.
We are legally required to investigate and report any complaints(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) . If we don’t get the complaint we can’t investigate and report it.
If a certain number(honestly I don’t know the specific number) of complaints occur we are legally required to create a corrective action to help the patients immediately (or as soon as possible) and a preventive action to ensure it doesn’t effect other patients. If a person has an issue and “repaired” it themselves they don’t get counted in this and as such could cause more patients to suffer.
While I agree with right to repair I think certain things should be exempt. That said then there should be a requirement of the manufacturer to ivestigate/repair the equipment.