M
Hi all,
We are a small (<20 employees) Canadian manufacturer of a specific scientific instrument. Our field of market is expanding gradually into clinical testing and we are looking to follow the trend. This means our instrument will have to become a medical device for us to enter that field. This means comply with ISO 13485 and FDA regulation.
Our primary market is the US so we asked the FDA via a 513(g) request to classify our device, it comes out to be a Class 1 and subjected to QSR. Our instrument is controlled by software so under 820.30 a) 2 i) it means we have to implement design controls.
The instrument was R&Ded years ago without any kind of design control. Even worse, we have next to no documentation on the design phase. No formal meetings were held, so no design planning / input - output definition were written anywhere. The design verification (testing of performance) was conducted quickly without any written trail / report. Forget about any risk management. Forget about a DHF... The software was also coded without any plans or requirements specifications.
As I see it, the requirements were conveyed verbally between a small team and we have next to no written records of the design phase.
We do have sparse electronic / mechanical plans, datasheets scrambled around in multiple folders without any structure.
The rest of the QSR is pretty well covered: over the years we implemented procedures, work instructions, tests to support the quality system we have in place. However to this date no design control procedure is established, even less followed.
After reading quite a bit about inspection I see that FDA inspectors ask to see proof that design controls were followed while designing the device. Which we can't produce...
My question: how could we comply to 820.30 (Design control) if none were followed in design? Is it impossible? If so it means to develop a new device from the design phase with the complete QSR implemented from the beginning?
Thanks
We are a small (<20 employees) Canadian manufacturer of a specific scientific instrument. Our field of market is expanding gradually into clinical testing and we are looking to follow the trend. This means our instrument will have to become a medical device for us to enter that field. This means comply with ISO 13485 and FDA regulation.
Our primary market is the US so we asked the FDA via a 513(g) request to classify our device, it comes out to be a Class 1 and subjected to QSR. Our instrument is controlled by software so under 820.30 a) 2 i) it means we have to implement design controls.
The instrument was R&Ded years ago without any kind of design control. Even worse, we have next to no documentation on the design phase. No formal meetings were held, so no design planning / input - output definition were written anywhere. The design verification (testing of performance) was conducted quickly without any written trail / report. Forget about any risk management. Forget about a DHF... The software was also coded without any plans or requirements specifications.
As I see it, the requirements were conveyed verbally between a small team and we have next to no written records of the design phase.
We do have sparse electronic / mechanical plans, datasheets scrambled around in multiple folders without any structure.
The rest of the QSR is pretty well covered: over the years we implemented procedures, work instructions, tests to support the quality system we have in place. However to this date no design control procedure is established, even less followed.
After reading quite a bit about inspection I see that FDA inspectors ask to see proof that design controls were followed while designing the device. Which we can't produce...
My question: how could we comply to 820.30 (Design control) if none were followed in design? Is it impossible? If so it means to develop a new device from the design phase with the complete QSR implemented from the beginning?
Thanks