Theoretical project: Implementing ISO 13485:2016 into a start up acrylic bone cement manufacturer

[ErnestoBurke]

Hi, I'm currently a masters student tasked with theoretically applying ISO 13485:2016 to a start-up medical device company. I have read the standard and have gained a grasp of its requirements. However, as this is a theoretical project I'm struggling to find details of the manufacturing processes associated with the product and also information to be included in the medical device file. Would anyone be able to point me in the direction of such information? Any help would be greatly appreciated

 

[William55401]

Welcome to the Cove. Requirements for manufacturing are found in 7.5 Production and Service provision. The overall section 7 Product Realization is where you need to focus. As the org responsible (or theoretical org), you must write (create) content that meets the requirements. What is the product? How is the product specified? What are the components or materials in the product? How are these sub items specified? The medical device file is explicitly defined in 4.2.3. Based on the product you are making, create content that aligns to 4.2.3 for EACH sub part. You know the product; you create the content that aligns to 4.2.3. I suggest you focus on definitions and read with great care. Very few individuals are expert in the entire standard. Good luck, have fun, enjoy the ride / theoretical ride. Hope this helps.

One more. If you can share WHAT product you are thinking about, I suspect you will get better feedback / questions to think about as you create content aligned to each explicit requirement of the 13485 standard.

 

[ErnestoBurke]

Welcome to the Cove. Requirements for manufacturing are found in 7.5 Production and Service provision. The overall section 7 Product Realization is where you need to focus. As the org responsible (or theoretical org), you must write (create) content that meets the requirements. What is the product? How is the product specified? What are the components or materials in the product? How are these sub items specified? The medical device file is explicitly defined in 4.2.3. Based on the product you are making, create content that aligns to 4.2.3 for EACH sub part. You know the product; you create the content that aligns to 4.2.3. I suggest you focus on definitions and read with great care. Very few individuals are expert in the entire standard. Good luck, have fun, enjoy the ride / theoretical ride. Hope this helps.

One more. If you can share WHAT product you are thinking about, I suspect you will get better feedback / questions to think about as you create content aligned to each explicit requirement of the 13485 standard.

Hi William, thank you for your reply! The project is based on the implementation of the standard in a theoretical Acrylic bone cement manufacturer so the product is a PMMA bone cement. I am currently working my way through the standard and have started to develop my theoretical quality manual.
I have my scope and exclusions justified, the quality policy written and I'm currently working on my quality objectives. Would you be able to provide any knowledge of common objectives as I have nothing to base this on?

Thank you for your help so far.

 

[William55401]

Assuming you are a new company with a new product, here are a couple of objectives to consider. Think about this from a QMS and product perspective. These high level objectives would trigger detailed project planning and executi.on

QMS objective: Define, establish, and implement a Quality Management System and obtain Notified Body certification by mm/yyyy.

Product objective: Secure regulatory clearance to market the PMMA bone cement in EU and USA by mm/yyyyy

 

[Zero_yield]

I know you're talking about ISO 13485 rather than FDA guidelines, but this guidance document may be useful.

Quality objects might include things like a "right the first time metric" (number of lots with no deviations divided by total number of lots produced) of a certain percentage or a target, complaints per million at a certain number or less, or percent of CAPAs effective.