notified bodies medical devices (nb-med)

  1. Marcelo Antunes

    Position paper Team NB Statement - Patient safety

    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...
  2. Marcelo Antunes

    Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body

    BSI achieves Designation for its Netherlands Medical Devices Notified Body BSI achieves Designation for its Netherlands Medical Devices Notified Body | BSI Group
  3. supadrai

    NB dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?

    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...
  4. D

    Notified body - CE Certification Class 2a Products in India

    Hi all, Am looking for Notified body for CE certification - Class 2a products in India, other than UL, DNV and TUV..
  5. Marcelo Antunes

    Medical Device News State-of-play of joint assessments of Notified Bodies in the medical device sector

    State-of-play of joint assessments of Notified Bodies in the medical device sector DocsRoom - European Commission
  6. B

    Our NB doesn't accept new clients for MDSAP

    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?
  7. H

    Clinical investigation - Role of Notified Body (NB)

    Hello 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...
  8. R

    Medical devices certified by different notified bodies

    Hi everyone, We have two nebulizers (Type A and B). They are the same except for the enclosure. Can they be separately certified by different notified bodies?
  9. S

    Portugal ISO 13485 Certification and EMC Test Houses

    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...
  10. S

    When will notified bodies be ready to perform audit to the MDR?

    Hi everyone, 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...
  11. K

    Questions on Technical File to show it is current

    Good Afternoon, 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...
  12. R

    Brexit - European Commission - The impact of the Brexit per March 29, 2019

    Dear all, last week the European Commission published a document outlining the impact of the Brexit per March 29, 2019. http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=612136 Depending on your economic operator role and where you are located, you might have to take actions as no CE...
  13. S

    The new "features" of the MDR - Dec 2017

    Hi Fellows, 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. Cheers, Shimon
  14. M

    OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope

    Hey guys, 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...
  15. R

    Independence on Notified Bodies, inter alia of Manufacturers they Assess

    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...
  16. M

    Authenticity of NB's

    Hi, 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...
  17. R

    Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding

    Hello All, Since the MEDDEV guide is not legally binding, I can challenge nonconformity issued by NB, like clinical evaluation does not take into account the MEDDEV 2.7/1 revision 4. Is that right? Best regards, Roland
  18. L

    Does anyone know what is going on in DQS?

    Does anyone know what is going on in DQS? In the commission website, DQS also got a "warning symbol", they are our notified body, if they are not competent, we will need to look for another NB quickly. Thanks for your help.
  19. S

    Nemko AS & DQS - Concern over notification as a Medical Device NB

    Does anyone know whether Nemko has lost ist accreditation for medical devices? There is a "warning symbol" on the comission website: "The Commission has not received assurance of the continuing competence of this NB concerning its tasks under 93/42/EEC Medical devices" What does that mean?
  20. S

    Literature Search - Notified Body Had Questions About our Rationale

    We have submitted our Clinical Evaluation Report to our notified body, and they came back with some cryptic feedback we're not quite sure what to make of it. We're taking the literature review approach, compliant to MEDDEV. 2.7.1 Rev.3. The main issue focuses on our Rationale for the...
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