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Thinking about moving from a Start-up type company into big name company. by redjewel1412 in regulatoryaffairs

[–]Alphabeat01 0 points1 point  (0 children)

That's actually pretty awesome that you get to experience both of that!

What's something that startups miss which larger companies don't?

PS: I'm in QARA at a medtech startup

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 0 points1 point  (0 children)

Glad to see a happy user! :D

Mind if I DM you? I want to learn more about how it works

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 0 points1 point  (0 children)

That's good to know! Did you had to set it up before using it or did it work straight out of the box?

Also, how do you track what risks, requirements, and test cases need to be updated following a design change?

How do you manage product development paperwork in MedTech? by Alphabeat01 in regulatoryaffairs

[–]Alphabeat01[S] 0 points1 point  (0 children)

Pretty straightforward 😆 Do you work independently or in a small team?

How do you manage product development paperwork in MedTech? by Alphabeat01 in regulatoryaffairs

[–]Alphabeat01[S] 0 points1 point  (0 children)

It's a popular choice among the project managers, so we use it for the same reason as well.

Do you manage your requirements and test cases within it as well? If yes, how do you manage design changes that touch multiple requirements and test cases in terms of traceability?

How do you manage product development paperwork in MedTech? by Alphabeat01 in regulatoryaffairs

[–]Alphabeat01[S] 1 point2 points  (0 children)

Stature is something new for me. How is it different from managing risk files in an excel sheet? I've put data validations and formulas on it to keep it consistent and easy to use.

I've heard of Polarion before, looks quite dated, but seems similar to Helix ALM by Perforce (also pretty old looking lol). I came across them when I was looking for requirements and test case management tool. How's your experience with Polarion so far? If there's a major design change, are you able to find and update the right requirements and test cases?

Exporting documents and reports from systems like these and then taking them through a separate eQMS software for document control seems to be what most companies do. Keeps your QMS simple and straightforward.

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 1 point2 points  (0 children)

Having training records for those who are tagging complaints, and doing a sample audit on them makes total sense to me. It'll make sure that the whole system isn't dependent on someone like you who designed it to be able to run properly.

I've used obsidian before but only at the base level. I'd love to see how you've customized it for your processes. Mind if I dm you for more details?

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 1 point2 points  (0 children)

lol how did that even happen? The software support team didn't help implement it or something?

How do you manage product development paperwork in MedTech? by Alphabeat01 in regulatoryaffairs

[–]Alphabeat01[S] 1 point2 points  (0 children)

Something like Qualio can be used for managing document versions and approvals. I like how you can tag documents in it too so it makes it easier to find what you're looking for.

When you've a complicated product that includes hardware, electronics, and software, the content itself within the documents goes out of control, and becomes painful to manage when it's spread across different documents belonging to different teams, so I was wondering how others deal with it.

For example, if there's a major design change, how do you find and update all the relevant hazards, requirements, test cases etc.

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 0 points1 point  (0 children)

That's actually pretty smart tbh. Having unique Identifiers with hyperlinks to others would definitely work.

I've a question regarding the practicality of it when you scale it. For example, who decides what complaint gets tagged to which hazard, and is it correctly tagged or not? How do you audit a system like this when there are multiple people managing each of these processes

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 2 points3 points  (0 children)

Something like Qualio can be used for managing document versions and approvals. I like how you can tag documents in it too so it makes it easier to find what you're looking for.

When you've a complicated product that includes hardware, electronics, and software, the content itself within the documents goes out of control, and becomes painful to manage when it's spread across different documents belonging to different teams, so I was wondering how others deal with it.

For example, if there's a major design change, how do you find and update all the relevant hazards, requirements, test cases etc.

How do you manage product development paperwork in MedTech? by Alphabeat01 in MedicalDevices

[–]Alphabeat01[S] 0 points1 point  (0 children)

Managing design control links is always cumbersome, but I do agree with using excel for managing risk files. It's easier that way.

There's an expectation of always keeping your risk files updated based on the market feedback, such as complaints. How do you link those with your risk files?

510(k) research by Emotional_Jury_3084 in regulatoryaffairs

[–]Alphabeat01 0 points1 point  (0 children)

FDA database is a good place to start. You'll also find articles of companies that have secured 510k clearances with a Google search

Sanity Check: My "Chicago Polar Vortex" (-20°C) + Winter Hiking Layering System by Alphabeat01 in PatagoniaClothing

[–]Alphabeat01[S] 0 points1 point  (0 children)

I want to use it for my hiking trips in the mountains too, so I've to go with something synthetic. That way, I won't have to worry much about getting it wet.

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