Class 1 Medical Device Contract Manufacturer Technical File Requirements

[lisawxf80]

Dear all,

My company is a contract manufacturer who will help to design and produce whatever customer required.

Our product range includes : Apron, Disposable, Surgical Crepe Paper, Alcohol Swabs, Paraffin Gauze, Examination glove, Forceps, Curve, Mosq, Clamp. Product diversity is large. We either buy some of the parts and assembly them into package or product some of them, eg: swab.

Due to the business inherity, we have a problem to initial and maintian a technical file for every product.

May I know
1.how should we creat those type of technical file and what could be the must have items & infos.
2. should I creat tech file for each individual product. The product could not have a proper design phase, it might be prouduced according to a sample received from customer or internal discussion by ourselves to meet customer requirements as our product is not high tech.

Currently we have to initial simple tech file for every customer with simple info, like size, folding method, cutting etc which looks not very professional.

Appreciate your advise.

Thanks & Regards,

Lisa

 

[Ronen E]

Re: Class 1 medical device technical file

Dear all,

My company is a contract manufacturer who will help to design and produce whatever customer required.

Our product range includes : Apron, Disposable, Surgical Crepe Paper, Alcohol Swabs, Paraffin Gauze, Examination glove, Forceps, Curve, Mosq, Clamp. Product diversity is large. We either buy some of the parts and assembly them into package or product some of them, eg: swab.

Due to the business inherity, we have a problem to initial and maintian a technical file for every product.

May I know
1.how should we creat those type of technical file and what could be the must have items & infos.
2. should I creat tech file for each individual product. The product could not have a proper design phase, it might be prouduced according to a sample received from customer or internal discussion by ourselves to meet customer requirements as our product is not high tech.

Currently we have to initial simple tech file for every customer with simple info, like size, folding method, cutting etc which looks not very professional.

Appreciate your advise.

Thanks & Regards,

Lisa

Hello,

First - What is the driver for these tech files? Customer requirements only? Some regulatory requirements?

Customer - just negotiate what you can do and are willing to do against the customer(s) requirements, and then document the agreements, sign-off (both you and the customers) and implement accordingly.

Regulatory requirements - what territory are you referring to (USA, EC etc.)?

Class 1 devices are typically exempt from Design Controls, so from a formal perspective it matters less how you arrive at the finalized design. It is still important to document the finalized design, and if it is a simple product which is captured in a simple manner - there's nothing wrong with it. Just make sure it's fully covered, with enough detail for reproduction.

Cheers,
Ronen.

 

[lisawxf80]

Re: Class 1 medical device technical file

Hello,

First - What is the driver for these tech files? Customer requirements only? Some regulatory requirements?

Customer - just negotiate what you can do and are willing to do against the customer(s) requirements, and then document the agreements, sign-off (both you and the customers) and implement accordingly.

Regulatory requirements - what territory are you referring to (USA, EC etc.)?

Class 1 devices are typically exempt from Design Controls, so from a formal perspective it matters less how you arrive at the finalized design. It is still important to document the finalized design, and if it is a simple product which is captured in a simple manner - there's nothing wrong with it. Just make sure it's fully covered, with enough detail for reproduction.

Cheers,
Ronen.

Hi Ronen,

Thanks for the info. My complany compliance with CE.

And if it is a simple one, may I know where can I find the guideline from. And the basic items in a template. thanks a lot!

Regards,

Lisa

 

[harry]

Related thread: CE MDD 93/42/EEC Class I Technical File Help