CE MARKING OF MACHINES
We can assist you throughout the whole process.
Training - Testing- Consulting

CE MARKING OF TECHNICAL PRODUCTS
We can assist you throughout the whole process. 
Training - Testing- Consulting

CE Marking of medical devices

Usability

CE MARKING OF MEDICAL DEVICES
Expert solutions to meet the requirements. 
Training - Testing- Consulting

USABILITY
Expert solutions to meet the requirements.
Examination

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SAASCO Help

 

News

  • 11.03.2021 - Vajda Papír launches a mask manufacturing plant with the professional support of SAASCO

    Vajda Papír has put into operation the modern production lines on which CE-marked surgical masks will be manufactured Dunaföldvár. The capacity of the plant will enable Hungary to become self-sufficient in masks to protect against the virus, stressed Finance Minister Mihály Varga at the launch of the plant. The investment was made with significant public support under the Health Industry Support Programme.


  • 01.03.2021 - Registration of legacy devices in EUDAMED

    Legacy devices are devices whose MDD certificate expires after 26.05.2021 or Class I devices for which a notified body is already involved for certification according to the requirements of the MDR. The legacy devices may be legally placed on the market until the expiry of the MDD certificate, but no later than 26.05.2024.


  • 16.02.2021 - A German hospital has been hacked, one patient has died...

    Back in September last year, hackers used ransomware to render the computer system of a university hospital in Düsseldorf unusable. As a result, care in the emergency department also collapsed and one patient who could not be treated died. According to the investigation so far, the extortion scheme caused a gradual breakdown of the hospital's system, with staff unable to access patient data and even to the point where they were unable to perform life-saving interventions.


  • 01.12.2020 - EUDAMED: the economic operators' registration module is now available!

    "The creation of a European database for medical devices (Eudamed) is one of the main aspects of the new rules on medical devices ((EU) 2017/745 - MDR) and in vitro diagnostic medical devices ((EU) 2017/746 - IVDR).


  • 02.10.2020 - When will there be MDR/IVDR harmonised standards?

    The quick answer to the question in the title is that no one knows... I could end the newsletter here, but let's look at what exactly happened in this case.


  • 2020.05.14. - ConformiTICs Lab

    We have established ComformiTICs Lab Ltd. specialized in conformity assessment. 


  

 

  

  

News

  • 20.10.2022 - Is my software SaMD or SiMD?

    At SAASCO trainings we always strive to use the Hungarian terminology and abbreviations of the given field and avoid the "hunglish" language that is so fashionable nowadays. However, this is becoming increasingly difficult, especially in the field of software.

  • 11.10.2022 - Guide to the MDR technical documentation

    In a previous newsletter, we reported on the MDCG's position statement outlining the measures needed to accelerate the MDR/IVDR transition. This included a proposal that the MDCG and Notified Bodies provide additional guidance to help manufacturers prepare for the transition. In this line, TEAM NB (The European Association for Medical devices of Notified Bodies) has published a guidance document entitled "Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745".

  • 05.09.2022 - How can the capacity and availability of notified bodies be increased?

    The Medical Device Coordination Group (MDCG) has issued a position paper to address the issues related to the MDR/IVDR transition, in particular to increase the capacity and availability of notified bodies.

    The MDCG states in the introduction to the resolution:

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