Hi,
Our company manufacture and sell medical devices, we are fully certified to ISO 13485, ISO 9001 and hold CE marking facilites
We have been approched by a company to design and develop a product. We would be the manufacturers and the product would be added to our 93/42/EEC Scope. The finished product would then be sold to and subsequently sold and distributed by the company who originally approached us.
Does this company need any certification ie ISO 9001 or ISO 13485? they would by named on the packaging as distributors, and ourselves as manufacturers.
Regards
J1980b
Our company manufacture and sell medical devices, we are fully certified to ISO 13485, ISO 9001 and hold CE marking facilites
We have been approched by a company to design and develop a product. We would be the manufacturers and the product would be added to our 93/42/EEC Scope. The finished product would then be sold to and subsequently sold and distributed by the company who originally approached us.
Does this company need any certification ie ISO 9001 or ISO 13485? they would by named on the packaging as distributors, and ourselves as manufacturers.
Regards
J1980b
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