What are the required procedures for Medical Device Specification Developer?

Hello, I will be working for a specification developer or virtual manufacturer of Class III (FDA), Class IIb (MDD) devices. In other words this company outsources both the design and development as well as the manufacturing of their devices.

I have read the ZLG and tried to determine from it, what quality systems must I establish for use by the Specification Developer/Virtual Manufacturer. I am still having trouble because if development and manufacturing are both outsourced, why would I need procedures for design control and product relization?

Need clarification of what procedures would need to say from the specification developer's prospective.

Thanks

QA Person

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

Are there any medical device folks here who can weigh in on this?

My appreciation in advance!

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

QAperson said:

...Class III (FDA), Class IIb (MDD) devices...this company outsources both the design and development as well as the manufacturing of their devices.

...if development and manufacturing are both outsourced, why would I need procedures for design control and product relization?

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FDA perspective:

Because, although you are allowed to outsource the actual work of designing and manufacturing, you are not allowed to shift legal responsibility for managerial control of designing and manufacturing to assure regulatory compliance of those activities. Thus you, the specification developer, must have effective managerial systems in place to monitor and control the work of your vendors.

It is common to think that outsourcing means no participation...you just sign the contract, pay the bills, and the work happens with no involvement on your part. This understanding is incorrect under FDA rules.

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

This is one of the reasons why legislation is tightening all the time. Ambiguity in regulatory matters is not tolerable.

Someone must own the device, and intend to manufacture it, and market it. That is the person or company that must comply with the appropriate regulations.

They will have to demonstrate to their regulatory authority, that they, and any subcontract they use, have complied with all the regulatory requirements for this device from conception to marketing.

Alex Kennedy

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

I agree with what has been said. Just want to add that the Competent Authorities (MDD) take the same position as the FDA does in this case.

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

Thanks for the responses. I appreciate this website so much. I have always accepted the responsibility for the quality of our contract developer and contract manufacturer for the medical device.

The question now becomes - are there any sample design control and production control procedures out there for a virtual manufacturer who does not do design control other that providing design input and who does not manufacturer the medical device?

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

QAperson said:

The question now becomes - are there any sample design control and production control procedures out there for a virtual manufacturer who does not do design control other that providing design input and who does not manufacturer the medical device?

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I think again your by definition trying to skirt around ownership of teh device by having someone else design and manufacturer the device. You as the owner must still facilitate control through the design, design transfer and manufacturing of the device to meet regs. In your position I would take it as an audit function. Is the designer an ISO certified group? how about the manufacturer (if they are different) Then I think you can lean on their systems and focus how you work the interface between the two. But its a nice tight rope you have there.

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

QAperson said:

are there any sample design control and production control procedures out there for a virtual manufacturer who does not do design control other that providing design input and who does not manufacturer the medical device?

Click to expand...

It is conceptually incorrect to say that you will not do design control.

Your high level procedures will be the same as those of a company that does all of its own work. The only difference will be that your procedures will be applied remotely, by personnel who work for someone else. You'll receive and maintain evidence of compliance, which might be in the form of declarations depending on quality systems in place. You may need to audit that compliance.

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

Reviving an ancient thread here...

So hypothetically:

If I were one individual who develops a new idea/technology, but had no resources to realize it into a device.

With lofty ambitions, I register a company (CompanyA), with an employee of one (me).

Now, with some scapped together capital, I contract another company (CompanyB) to design, test, manufacture, package the device for me. They are ISO13485 certified.

They ship me finished devices (including labelled with brand CompanyA + "manufactured by CompanyB"), and all I do is distribute.

- I (CompanyA) maintains distribution records
- Any feedback is forwarded directly to CompanyB
- Any servicing, returns, etc. are handled by CompanyB

So here is the question:
- Do I have to be ISO13485 certified, even though nearly all activities are done by another company?

Re: ISO 13485 for Specification Developer for Virtual Manufacturer of Medical Devices

I'm going to go out on a limb and answer my own question, and say that yes, ISO13485 certification would be required for my lowly company of one, because I'd be legally responsible for all activities.
Can anyone confirm this assessment or input?

If so, what a burden! This may be getting off topic of this thread, but is it possible to have a "skeleton" 13485 system in cases like this? For example "7.3 Design and Development" would be a procedure stating simply "All design and development activities will be contracted to ISO 13485 certified 3rd parties"?