• 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:

  • 25.08.2022 - New proposal to speed up the MDR certification process

    Despite considerable efforts by the European Commission and the MDCG, there is growing concern about manufacturers' preparedness for the MDR transition. With less than two years to go until the mandatory application of the MDR, around 24,000 certificates will expire. In June, the MDCG issued a position paper (MDCG 2022-11) in which it stated:

  • 17.06.2022 - Share your experiences in connection with your notified organisation!

    In order to make the regulation of medical devices more transparent, the OPENREGULATORY team wants to help companies choose the right notified body. Previously, companies have been reluctant to publicly share their experiences with notified bodies. They wanted to change this by providing a place where everyone can share their stories anonymously.

  • 27.05.2022 - IVDR mandatory from today

    From 27.05.2022, 00:00, the application of the IVD Medical Device Regulation (IVDR) (EU) 2017/746 is mandatory!

    Our first open training on IVDR was held on 01.06.2017, when the 5-year transition period still seemed very long. Even then, the quantity and quality of the migration work was a cause for concern, but everyone thought that five years would be enough. At the time, of course, we never dreamed of the COVID-19 epidemic or that not only manufacturers were having difficulty adapting gearboxes, but that the EU was also very slow to comply with the tasks imposed on them by the regulation. Where are we now, when the original idea was that all the conditions should have been met:

  • 01.04.2022 - What are the leading companies in the medical device market doing differently?

    Greenlight Guru conducted a survey of medical device industry professionals on product development, quality management and marketing. More than 500 quality, product development and management professionals were surveyed. The study has many interesting lessons, which we will try to summarise briefly:

  • 16.02.2022 - CE marking of Industrial Machines

    During the training, we will go through each step of the CE marking of machines and safety equipment.

  • 16.01.2022 - Technical requirements for CE marking of Industrial Robot Systems

    Our new, practical approach focuses on introducing the technical requirements for robot systems and their CE marking for collaborative applications. 

  • 06.01.2022. - Conformity Experts is a member of QTICS Group

    We are delighted to inform all our Partners that Conformity Experts is a member of QTICS Group. QTICS is an acronym consisting from the first letters of Quality, Testing, Inspection, Certification and Services.

  • 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.