SK13485
MedDev QA/RA
Hi,
Do you have a Medical Device Post Market Surveillance plan? This system has been there for some time in few markets. Are the regulatory agencies currently in an enforcement mode to apply this to the Medical devices? Have your auditor audited your PMS system or asked any questions or raised any concerns?
Some of the regulatory agencies got the plans well detailed. But they never talk about anything in terms of the acquisition of data. They want to enforce this on to the manufacturers with all regulations set forth for us. How about the Hospitals and Clinics and other research facilities? Why don't they have some regulations in place for them as well to co-operate with the manufacturer for PMS?
Talking about the proactive monitoring, We had a hard time so far. The feed back, surveys and so on we receive from our clients are incomplete. That data is not useful. Customers want our sales guys to buy them lunch for filling surveys. lol.. This is totally on another level...
I would be glad to hear your stories on implementation of PMS in your organization. Please feel free to join this conversation and share your ideas.
LETS CAGE THE ELEPHANT
SK
Do you have a Medical Device Post Market Surveillance plan? This system has been there for some time in few markets. Are the regulatory agencies currently in an enforcement mode to apply this to the Medical devices? Have your auditor audited your PMS system or asked any questions or raised any concerns?
Some of the regulatory agencies got the plans well detailed. But they never talk about anything in terms of the acquisition of data. They want to enforce this on to the manufacturers with all regulations set forth for us. How about the Hospitals and Clinics and other research facilities? Why don't they have some regulations in place for them as well to co-operate with the manufacturer for PMS?
Talking about the proactive monitoring, We had a hard time so far. The feed back, surveys and so on we receive from our clients are incomplete. That data is not useful. Customers want our sales guys to buy them lunch for filling surveys. lol.. This is totally on another level...
I would be glad to hear your stories on implementation of PMS in your organization. Please feel free to join this conversation and share your ideas.
LETS CAGE THE ELEPHANT
SK