If the U.S. fabrication site will be the one used for the future planned CE marked / European device version, then it would be a strategic benefit that the chosen U.S. ISO 13485 registrar for the U.S. site's ISO 13485 registration be part of a registrar that also offers European Notified Body (NB) services. That way, if you decide to eventually add a CE mark to the subject device manufactured at the U.S. site, then the registrar will already have a baseline certification and audit experience/records for the U.S. site, thus paving the way for the NB side of the registrar's operation to leverage that baseline and perhaps make the CE leap smoother, more streamlined, and less expensive.
We would need more details about your specific case to give definitive direction. But in general, remember that a European "mother" company wishing to market in Europe's Union its implantable devices under its name but fabricated in the U.S. must still work through an NB as part of gaining/maintaining the CE mark for those U.S.-made devices unless the CE mark would instead be done by the U.S. company as the responsible/labeled manufacturer. The CE marking requirements and associated quality management system (QMS) requirements still apply even when device manufacturing is outsourced to a daughter company; indeed, such daughter company's U.S. site may still be subject to assessment by the NB as part of the mother company's QMS conformity assessment, and of course for certain if the U.S. site will be the labeled manufacturer.
The experience I have with the U.S. registrars I use for my clients is that they are generally 3-6 months out for scheduling the Stage 1 and 2 audits. Expect to pay the registrar 10-20K for the certification.
Feel free to contact me offline for further information about such ISO registrar / NB hybrid organizations or even just regarding the U.S. registrar aspect even if you don't aim to plan ahead and instead just want to focus on the here-and-now by hiring a U.S. registrar without regard for its NB capabilities.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 17-Mar-2024 08:23
From: Anonymous Member
Subject: US registrar for ISO13485 certification
This message was posted by a user wishing to remain anonymous
Due to changes in business strategy we are looking for a US registrar to ISO13485 certify our US based company. Currently the ISO13485 certificate is held by the mother company located in Europe, the certification is done by a EU notified body. However, since all manufacturing activity is to be redirected to the US we are now looking to certify the US entity instead. Adaptation of the QMS accordingly is ongoing.
The company sells 510(k) cleared implantable devices which are currently not CE-marked but may be in the future. I would like your advice on the following:
1. 1. Recommendations for US registrars that can provide ISO 13485 certification for manufacturing of implantable devices.
2. 2. If you have similar experiences and can give estimates of time and cost for ISO13485 certification process with a US registrar that would also be greatly appreciated.
Thank you in advance!