Nick,
I have many years of experience implementing Software Life Cycle Development Processes (and all the documentation associated with it) in compliance with the requirements established in both: FDA Guidance and IEC 62304. My experience is in Implantable Medical Devices (with embedded software) (Class III), and based on the limited information that you are sharing, I think that your project is very easy, and you don't need to pay for a consultant. You guys can do it by yourselves with some help. You are buying an off the shelf device with embedded software, and you are not modifying anything in the software code, so there are several documents/testing ( strictly associated with software) that you don't have to create because you guys didn't write the code.
Although the amount of documents depends on 100% of the Level of Concern/ Sofware Safety Classification, I can tell you from the top of my head that you don't need to create a Software Requirements Specifications (SRS), nor a Software Design Specifications (SDS), because this is an Off The Shelf device with embedded Software . (Off the Shelf = a commercially available reader), perhaps you meant a URS (User Requirements Specifications). You normally write a URS before purchasing an instrument, piece of equipment, software, etc in order to make sure that you are buying a device suitable for your intended use,
Question: Have contacted the manufacturer of the LFA Reader and ask him for any Validation Documentation?
Again, documentation requirements for an Off the Shelf Software are minimum [depending on the Level of Concern (FDA) / Software Safety Classification (IEC 62304)]. I can help you and guide you and your team through the entire process. Then I can help your regulatory person (urself?) to complete the submission.
Not having any specific details of the LFA system and the intended use makes it difficult for me.
If you are purchasing
the LFA reader and using it "as is" then you have to follow FDA Guidance for Off-The-Shelf Software Use in Medical Devices. Then if you guys are planning to register this product in Europe, you have to complete the Software Life Cycle Development Plan in compliance with IEC 62304. Software Documentation from FDA and IEC 62304 is pretty much the same, the difference is basically the naming and a few other important details that you learn as you work in the documentation.
Before moving forward with any discussion, you need to formally document the Software Level of Concern (Per FDA), Software Safety Classification ( per IEC 62304).
I am not a consultant. In fact, I am a full-time employee (Engineering Manager) in a large company, but I also do some extra work aside. It will be my pleasure to help you to implement the full process. If you want my help, then my advise is to complete an NDA (Non-Disclosure Agreement) so you can provide me more specific details about the project.
Best Regards,
Nina J
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Nina Joyce
Bay Village OH
United States
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Original Message:
Sent: 27-Jun-2019 14:15
From: Nicolas Garrett
Subject: Need recommendations for software/electrical component consultants for IVDs
Hi Nina,
We're looking for someone to help create the documentation associated with a Software Life Cycle Development Process to validate the LFA Reader. My colleagues and I have read through IEC 62304 and have a very basic understanding but we lack the experience of applying the standard. Some help with creating a Software Requirements Specification (SRS) and such for FDA submissions would be great too.
We're purchasing the LFA reader and using it "as is". We are making no changes to the internal workings/software of the device other than calibrating it to read our LFA strips.
Thanks so much for responding.
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Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States
Original Message:
Sent: 27-Jun-2019 12:17
From: Nina Joyce
Subject: Need recommendations for software/electrical component consultants for IVDs
Hi Nicolas,
Are you in search of a consultant to help you to create all of the documentation associated with a Software Life Cycle Development Process to validate the LFA Reader? ( then updating the TF with this info)
Or you are searching for someone to develop the Embedded Software?
Best Regards,
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Nina Joyce
Bay Village OH
United States
Original Message:
Sent: 27-Jun-2019 11:41
From: Nicolas Garrett
Subject: Need recommendations for software/electrical component consultants for IVDs
Still hoping for responses.
Again, any help would be greatly appreciated.
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Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States
Original Message:
Sent: 24-Jun-2019 09:19
From: Nicolas Garrett
Subject: Need recommendations for software/electrical component consultants for IVDs
Hello all,
I work for an IVD manufacturer that makes lateral flow assays and sells globally. Recently, we have been creating a plan to add an LFA reader to our IVD kits to aid in reading the assay. We have never needed electrical or software info for our technical files, processes, or submissions so this is new ground to us. We want to make sure we do it correctly and aren't missing anything important.
Does anyone have any recommendations for consultants who could help us with this?
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Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States
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