MIREGMGR
22nd August 2008, 04:40 PM
We make a large number of different Class I medical devices that, for various reasons, we want to review for potential risk in regard to our optimum labeling approach. All of these devices are intended for use by or under the supervision of medical professionals. None are intended for use by consumers or unsupervised patients. Most of these devices originated as long as thirty years ago, and we have no records of their original design genesis other than a general knowledge that they were suggested by medical-professional customers of our distributors, and in most cases informally validated by testing by such end users. In some cases we don't even have a full understanding of how they're used, even though we've sold thousands of them over the years.
FDA 21 CFR 803 provides that certain aspects of risk applicability are only permitted to be determined by "persons qualified to make a medical judgment", which is defined to include "physicians, nurses, risk managers, and biomedical engineers".
As a typical manufacturer, we don't have any of the above on staff. We do of course have consulting relationships, but that's not a very business-efficient approach if a lot of individually small decisions are needed.
In the medical field, it seems that most risk managers are focused on clinical care, as a requirement of JCAHO standards and thereby of insurance providers. Can anyone recommend a professional organization for medical risk managers that has a significant focus on device design and manufacturing? How about a discussion forum like this one that pertains to medical risk management?
Is anyone here a formally qualified Risk Manager as well as a QA/RA professional?
FDA 21 CFR 803 provides that certain aspects of risk applicability are only permitted to be determined by "persons qualified to make a medical judgment", which is defined to include "physicians, nurses, risk managers, and biomedical engineers".
As a typical manufacturer, we don't have any of the above on staff. We do of course have consulting relationships, but that's not a very business-efficient approach if a lot of individually small decisions are needed.
In the medical field, it seems that most risk managers are focused on clinical care, as a requirement of JCAHO standards and thereby of insurance providers. Can anyone recommend a professional organization for medical risk managers that has a significant focus on device design and manufacturing? How about a discussion forum like this one that pertains to medical risk management?
Is anyone here a formally qualified Risk Manager as well as a QA/RA professional?
