Hello Everyone,
I am very new to this space, but have consumed a lot of information since the last two hours after my reg. I am new to Quality as well, as I am taking this course in Quality Systems as a part of my assignment. I have been asked to design a project which consists of a design inputs document for a class 3 medical device. I would like to have some advice from you experts to provide me some pointers or a flow so as to start with the documentation- as basic as how many pages it should be to real complex one that I can't think of . I would really appreciate the help especially from the industry and will treasure it to the core :)

Also I have attached the problem in detail. I don't need direct answers from you guys but as I mentioned before some pointers to think.Thanks a lot ! I have found real great resources for my project and future projects in real industry. Thanks again for your replies.

Welcome,

I can guess what is the 'BION' that you are referring to but to make it clear to everybody, could you please elaborate?

I would like to have some advice from you experts to provide me some pointers or a flow so as to start with the documentation
Hi Shraddha & welcome to the Cove.

Just to focus on my area of expertise I would expect to see extensive DI's for the sterilization of the BION, as it is an implantable device. For sterilization, the DI's you need to include are:

Choice of sterility assurance level (10 to the -6 should be the goal for this type of device, IMHO)
Choice of sterilization method (including material compatibility with physical sterilization parameters; packaging requirements for aseptic presentation to implantation team; sterilizability of the device [as I understand it the BION is a sealed glass "capsule" with some electronics inside and thus the sterilization method must be able to penetrate the glass, so Gamma or dry heat]; and resistance to repeated sterilization cycles, if required (reuseables primarily)These DI's will lead to the choice of packaging configuration and a cycle design as a design outputs.

Always ensure that you consider the stresses of sterilization on the product when going through design - "ambient" just won't do it.

In addition the choice of method will have an influence on the "cleanliness" requirements for the manufacture of the device itself, so consider adding a DI route for product cleanliness, either clean manufacture, or washing/decontamination, to ensure final product bioburden is managed appropriately.

This is just one of the numerous DI streams that you are going to need to capture for this type of device.

Good luck

Jimmy

Yes sure

Hey Jimmy,
Thanks a lot for your response.

I'm still not quite sure what a BION is, it sounds similar to a pacemaker, albeit for the brain.

You might want to break the design inputs down into manageable chunks:

Clinical requirements - what is the device actually to do, and how will it achieve that, and how will it be proven to do that. (A clinical trial will almost certainly be required)

Surgical requirements - how will the surgical team use the device. Will training by the manufacturer be mandatory for sale?

Patient requirements - does the recipient have to do anything?

Engineering requirements - size, shape etc.

Safety requirements - electromagnetic compatibility

Manufacturing requirements - how will it be made, how will it be packaged, how will it be sterilised (see Jimmy's note above), how will it be transported?

Lifetime of the device - Obviously after sterilisation but before use (shelf-life), but maybe also after opening but before activation, after activation in the surgeon's hands but before implantation, inside the patient etc.

Materials of construction - biocompatibility, sterilisation compatibility, compatibility with drugs etc etc

Regulatory requirements - which countries might this product likely be sold in? What are the requirements of those countries?


Also look at the Essential Requirements in the (European) Medical Device Directive, that's a useful list of other critical design inputs.