Hi All,
I need help in understanding requirements of the QMS and UK regs for Medical devices. I work for a start up company (current company) who has a new medical device (company is ISO13485 certified). Top management wants the new medical device UKCA marked following a clinical investigation. They also want to spin out this new medical device under a new company name, whilst also be fully owned by the existing company.
To UKCA mark the device it will need to under the current company's QMS. Would the new company subcontract the medical device from the current company? Can all activities of the QMS be subcontracted? IF this is the case can the new company be the legal manufacturer?
Any help on this would be appreciated. TIA.
I need help in understanding requirements of the QMS and UK regs for Medical devices. I work for a start up company (current company) who has a new medical device (company is ISO13485 certified). Top management wants the new medical device UKCA marked following a clinical investigation. They also want to spin out this new medical device under a new company name, whilst also be fully owned by the existing company.
To UKCA mark the device it will need to under the current company's QMS. Would the new company subcontract the medical device from the current company? Can all activities of the QMS be subcontracted? IF this is the case can the new company be the legal manufacturer?
Any help on this would be appreciated. TIA.
