Primeiro NB designado para o MDR – BSi UK
First NB designated to the EU MDR regulation – BSI UK
I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't...
Position paper Team NB Statement - Notified bodies work within a strict regulatory framework and put patient safety at the heart of their decision making when conducting the conformity assessment of a medical device...
Does anyone have the inside scoop - are all the NBs slammed this year and just trying to grind it out? Our customers are getting antsy about placing orders ... and the NB failed to respond completely for a month, then punted to another team without providing any good response. Thoughts? Ideas...
We are planning to open Canada Market of a company which manufactures class IIa devices.
Our problem is that our Notified Body (SGS) is not accepting new clients for MDSAP.
What can we do? Is it possible to use another NB only for this qualification?
I am working towards CE marking of Class IIb device under the new IVDR, and am wondering what the role of the NB is during the clinical investigation/trial stage as part of the CE marking process.
Obviously our competent authority will be notified and cleared to perform the...
I have a Portuguese client (start-up) whose stakeholders are requesting we use Portuguese companies where possible.
1. Do any of you know any ISO 13585 notified bodies based in Portugal for Non-active general medical devices? Also in the future who can perform MDSAP audits.
2. Test House...
Does anyone know when notified bodies will be ready to perform audit to the MDR? Say a company is planning an audit directly to the MDR requirements (and does not hold an MDD certificate so there is no transition), when should this company expect to have their first MDR audit...
I really just want to scream right now so I am hoping someone here can talk me off the ledge.
Ok, during our recent unannounced NB audit we were given a finding because the particular Tech File for the product they were observing during the audit wasn't up to date. What I...
Dear all, last week the European Commission published a document outlining the impact of the Brexit per March 29, 2019.
Depending on your economic operator role and where you are located, you might have to take actions as no CE...
I recently attended a workshop with MDC (one of the notified bodies) and listened to two webinars on the MDR.
Attached are my personal notes on the key changes in the MDR for your learning.
This seems like a dumb question but just to be very sure:
The OEM manufacturer of the devices mentioned in the product scope of the OBL's ISO 13485 & EC cert, must have a valid ISO 13485 & EC cert of their own.
If their certs do not cover those devices, then the NB of the OBL will...
The new MDR speaks a lot of NBs impartiality and independence, inter alia of Manufacturers they assess. Is that even possible where manufacturers hire the services of NBs, which are essentially commercial entities that need to stay financially afloat? Apparently there's a built-in conflict of...
Is there any website other than the Nb's which i can look up for checking:
The authenticity of a NB ?
Whether the NB is authorized for medical device directive ?
Which class of medical device can they audit ?
Certificates issued by them are falsified or not?
Any help would...