1. GStough

    Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate?

    While reviewing suppliers' ISO certificates, our supplier quality clerk noticed that one of our suppliers has an ISO cert with both standards. Also, the cert does not have the ANAB or UKAS logo, but rather the Swiss Accreditation logo. When the new versions of these standards were released, we...
  2. G

    How to place a medical device in Switzerland (Regulations)

    Hello Elsmar,:bigwave: As Switzerland dont come under European Economic Area (EEA) , how medical devices are regulated in this market? :confused: I would appreciate a detailed info if possible:applause: Best Regards, Gargi :thanks::thanks:
  3. A

    ISO 14644 training in Austria, Germany and Switzerland

    Dear all! As you know - ISO 13485 refers to the ISO 14644 standard. Can anybody give me a hint - where can I find organisations or trainers for this ISO 14644 standard? (if possible in Austria, Germany or Switzerland). Thanks a lot in advance for your feedback! BR Aphel
  4. D

    Medical Devices technical lists for Germany, Austria, Sweden, Switzerland, etc.

    Hi! In my company we are currently developing a new area of expertise related to Medical Devices (MD) reimbursement. I?m looking for a technical list of medical devices (used in a hospital setting) in many different countries, but it seems like it?s not publicly available. For example...
  5. M

    Veterinary Use device regulation - Serbia, EU and Switzerland

    Dear all, I'm looking for some information regarding devices with veterinary use regulation in the following Countries: - European Union; - Serbia; - Switzerland Does anyone know anything about this issue in these Countries? Plaese answer me as soon as possible for you, bye...
  6. J

    Declaration required for MD First Marketing in UK, DE, CH, BE and NL

    Good morning, I would be grateful if someone could provide with the requirements for first marketing of a CE marked medical device in the following EU countries: - United Kingdom - Germany - Switzerland - Belgium - Netherland. I know that such a "declaration" is required in France, Italy or...
  7. A

    Whom should I send the FSCA (Field Safety Corrective Action) to?

    Dear all, With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated: "Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY...
  8. S

    Class III Medical Device Registration and Requirements in Iraq

    Hello all, Does anboy have an idea what is needed to register a CLASS III Medical Device in Iraq? We would ship the products out of Switzerland. I couldn't find anything about this. For me it looks like there is nothing needed?!?! Any help would be very appreciated. Thanks
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