New ISO 13485:2003 CMDCAS question - Company Restructured

[peter21]

Hi Everyone,

We own a company in Canada that has 6 employees. Until very recently, we used to be private label manufactures for a company that had a 13485:2003 certificate issued by a CMDCAS approved auditor. However, unfortunate circumstances (buyout, restructuring) have caused this company not to continue developing the products that we were selling.

As a result, and after a lot of research, the only option for us is to obtain pre-assembled electrical components from one company and all other components from another company. We would have to assemble the components and thus, it would make us the manufacturer of such products.

Under canadian regulations, we need to implement an ISO 13485:2003 that would have to be certified by a health Canada CMDCAS accredited registrar.

Do these companies fall under the definition of oursourcing or are they just suppliers? Do they need to also implement an ISO 13485:2003 and if so, does it have to be under canadian regulations as well? We are a bit confused when it comes to this bit as it's a big step forward for us from private label to manufacturer.

Thanks

 

[DannyK]

Re: new iso 13485:2003 CMDCAS question

Peter, the answer to your question depends on a few factors. Are the items supplied considered to be medical devices? Are they the only source for these items?
If the items supplied are not considered medical devices, the companies do not necessarily have to get ISO 13485:2003 since they are only components of medical devices. They certainly do not have to get certified for the canadian regulations.
As suppliers, you have to demonstrate control over your suppliers, especially those that are considered as critical ones. Controls to be implemented could be annual audits, extensive receiving inspection, etc...

 

[peter21]

Re: new iso 13485:2003 CMDCAS question

Thanks for your answers.

One manufacturer takes care of obtaining the parts to build the inside of the device and 90% of the assembly. The other takes care of the 'look' of the device. We take care of putting both of them together. The first manufacturer can almost build the whole device. You can say that the items are components although, in the case of the first company, do you think it can be considered a medical device? That is, if a device doesn't come fully assembled, is it considered a medical device or will it still be considered parts to build a medical device?

Thanks in advance,
Peter

 

[DannyK]

Re: new iso 13485:2003 CMDCAS question

Thanks for your answers.

One manufacturer takes care of obtaining the parts to build the inside of the device and 90% of the assembly. The other takes care of the 'look' of the device. We take care of putting both of them together. The first manufacturer can almost build the whole device. You can say that the items are components although, in the case of the first company, do you think it can be considered a medical device? That is, if a device doesn't come fully assembled, is it considered a medical device or will it still be considered parts to build a medical device?

Does the first company sell the product to anyone else?
Do you test the product that is provided by the first company?
You may have to be a little more specific. You can send me a private message

 

[somashekar]

Re: new iso 13485:2003 CMDCAS question

Does the first company sell the product to anyone else?
Do you test the product that is provided by the first company?
You may have to be a little more specific. You can send me a private message

The PM can be an option, however we encourage active participation in the forum threads and with specific information as long as the poster takes care of his other confidentiality requirements. Many visitors here now and in future will get the benefits from such business linked regulatory discussions.
Thanks to all ...

 

[somashekar]

Re: new iso 13485:2003 CMDCAS question

See the guidance document GD210 of Health Canada, specifically the clause 2.3.2.4 (Auditing of suppliers or outsourced processes)