Does Anyone Have A Good Description Of The Roles & Respons. Of Independent Reviewers In Medical Device Design Reviews?

[Halfon]

I work for a medical device company and we are required to conduct design reviews for new products. Each review is required to have at least one attendee in the role of an independent reviewer, and some people are more effective than others in playing that role. I would like to offer some basic guidelines for doing an effective job as an independent reviewer, but I haven't been able to find any good references for that sort of information.

[Tearley]

Browse the American Society for Quality website. Be advised from the outset that you may have to be a member to really drill down to the best information(I'm a member) but some is freely available.The American Society for Quality can be found at www.asq.org. From the main page, look on the left-hand side for the Medical Division and browse their features.You can also search for the terms you mentioned for reprints of articles or directions to other sites with more specific information. On the topic you asked about, medical device design, you might try the following:Quality in Medical Deviceshttp://www.asq.org/medical-devices/Design & Construction Divisionhttp://www.asq.org/designYou may also find pertient information in the following articles:Risk Management of medical deviceswww.asq.org/members/news/aqc/58_2004/20110.pdf7 steps for improved safety for medical deviceswww.asq.org/pub/qualityprogress/past/0901/qp0901rooney.pdf While I'm not part of the medical division, I have seen similar exercises and internal audits and reviews of designs in other fields besides medicine under the ASQ umbrella, so I feel certain that the organization has information you can use. As I said, though, I don't know how much you can access without being a member, but it won't hurt to try.Good luck. Sources: www.asq.org newbie1554701 82 months ago Please sign in to give a compliment. Please verify your account to give a compliment. Please sign in to send a message. Please verify your account to send a message.

[Colonel]

Be advised from the outset that you may have to be a member to really drill down to the best information(I'm a member) but some is freely available.The American Society for Quality can be found at www.asq.org. From the main page, look on the left-hand side for the Medical Division and browse their features.You can also search for the terms you mentioned for reprints of articles or directions to other sites with more specific information. On the topic you asked about, medical device design, you might try the following:Quality in Medical Deviceshttp://www.asq.org/medical-devices/Design & Construction Divisionhttp://www.asq.org/designYou may also find pertient information in the following articles:Risk Management of medical deviceswww.asq.org/members/news/aqc/58_2004/20110.pdf7 steps for improved safety for medical deviceswww.asq.org/pub/qualityprogress/past/0901/qp0901rooney.pdf While I'm not part of the medical division, I have seen similar exercises and internal audits and reviews of designs in other fields besides medicine under the ASQ umbrella, so I feel certain that the organization has information you can use. As I said, though, I don't know how much you can access without being a member, but it won't hurt to try.Good luck.