Implementing ISO13485 in a new startup company - Neurological devices

[SimonChan78]

Hi all,

My company will be establishing the ISO13485 standard for our neurological devices.

As we are a start-up company , what will be the best way to go about it in terms of cost saving?

Appreciate you help in this matter.

Thanks
Simon

 

[somashekar]

Re: New to ISO13485

Hi all,

My company will be establishing the ISO13485 standard for our neurological devices.

As we are a start-up company , what will be the best way to go about it in terms of cost saving?

Appreciate you help in this matter.

Thanks
Simon

Hi Simon...
Welcome to the cove...
Now that you have registered, by visiting your www.Elsmar.com forums and exploring all related threads for information and by visiting Post attachment where you can get plenty of worthy materials, forms / formats and presentation stuff, you can learn a lot about ISO13485 and save a lot of money and time.
But the best thing you can do is ask specific questions in the related sub-forums and seek response. Same time do not miss to see the similar discussion threads which you can find right down every page.

 

[SimonChan78]

Re: New to ISO13485

Dear all,

If my product design is outsourced , can i exclude clause 7.3 Design and development ?

Thanks

 

[harry]

Re: New to ISO13485

...................... If my product design is outsourced , can i exclude clause 7.3 Design and development ? .......

Welcome to the Cove.


No. The 'determinant' is who is responsible for the design and not who carry out the design. When you outsourced, you are still responsible to provide input to the design, participate in the verification, review and validation and finally approve the final design.

 

[Marcelo]

Also, you can only exclude if the applicable regulatory requirements permit you to do so.

 

[SimonChan78]

Thanks for the information.

I am wondering if i need to include the DMR on the document control , as the MDD not going to distribute to USA ? And the only standard my company conform to is just ISO 13485.


Sorry if i have asked a repeated question.

regards

 

[Marcelo]

ISO 13485 does require a DMR, it only does not use that name. It's the "file" mentioned at the end of 4.2.1. If you only have the DMR, then it needs to be part of the ISO 13485 system to fulfill that requirement,

 

[SimonChan78]

Sorry for the many questions here; for the standards and guideline in the QMS, does the company need to include ISO 14971 for risk management?

 

[Marcelo]

Risk management yes (ISO 13485 requires risk management, although it's not very clear what the expectations are), ISO 14971 not necessarily, although it's best to use it.

Another tip - ISO 13485, and related standards, are not really standards to create a quality system, they are standards to evaluate quality systems.

If you want a document to guide you in creating a good quality system, you might take a look at ISO 9004, or a good book such as the ones from David Hoyle (my recommendation is aways the ISO 9001 Quality Systems Handbook).

 

[njhoost]

Not to trample on anyone, or repeat anything but I must emphasis Document Controls (Approvals, Numbering, Revision Control, etc.) and Authority Identification and Designation (i.e. Process Owners, etc.). Basically making sure who makes and/or approves the docs and they are allowed/empowered to do so, revisions and recessions are well tracked.

Do it from the beginning. And honestly, any question you have will have a 97% chance of having already been well covered in another post. So always search well first.

Good luck.