A
Hi,
We are a start-up medical device company with a full time-staff of nine.
We have a CEO, Head of R&D, Head of RA/QA, Head of Operations and Purchasing, and a part time CFO.
We are still at the design stage of our product, and hope to test our core-technology on an experimental prototype within 2-3 months. We have regular (every 1-2 weeks) meetings on the design status of the project, essential R&D items to be purchased, QA matters, problems, etc.
We have a full set of company procedures according to ISO 9001 and 13485.
Question: Can the accumulated regular meetings "take the place of" the Management Review (MR), as the MR would be very limited in scope if we were to have one? (of course, the meetings are recorded, with Action Items, follow-up, etc. )
If so, I assume that I would need to revise our MR procedure in order to "equate" our regular meetings to the MR.
I would appreciate any input on this.
Thanks a lot.
Asherlee
We are a start-up medical device company with a full time-staff of nine.
We have a CEO, Head of R&D, Head of RA/QA, Head of Operations and Purchasing, and a part time CFO.
We are still at the design stage of our product, and hope to test our core-technology on an experimental prototype within 2-3 months. We have regular (every 1-2 weeks) meetings on the design status of the project, essential R&D items to be purchased, QA matters, problems, etc.
We have a full set of company procedures according to ISO 9001 and 13485.
Question: Can the accumulated regular meetings "take the place of" the Management Review (MR), as the MR would be very limited in scope if we were to have one? (of course, the meetings are recorded, with Action Items, follow-up, etc. )
If so, I assume that I would need to revise our MR procedure in order to "equate" our regular meetings to the MR.
I would appreciate any input on this.
Thanks a lot.
Asherlee