EU MDR and EU IVDR published 0

They are here. Long expected, hard debated and with major impacts for industry. The new European Regulations for Medical Device (MDR) and In Vitro Diagnostics (IVDR) are published on May 5, 2017.  A new era has started. This will affect all medical device manufacturers having currently device on the EU market: All devices will have to be recertified. No grandfathering option is included. For the MDR, 3 years transition time is granted, for the IVDR, 5 years transition time is granted. Even though that appears to be a long period, a closer look on the timelines shows that companies will [&hellip

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Posted on 9, May 2017

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Bioforum ISO 13485:2016 & new EU MDR event 0

On December 13 and 14, Bioforum Ltd in Israel organized 2 days on new QMS and regulatory developments in the medical device industry. On the first day, despite the unusual stormy weather, a full room paid close attention to the changes between the QMS standards ISO 13485:2003 and ISO 13485:2016. Both Robert van Boxtel and Veronique Jasner presented the details on what is new and changed in this international standard. At the end of the day, the most effective approach to perform a gap analysis was presented. And, the message is clear: make sure that your QMS is upgraded and [&hellip

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Posted on 15, December 2016

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Cursusgids voorjaar 2017 0

De MDProject Cursusgids Voorjaar 2017 is beschikbaar, u kunt hier de Cursusgids 2017 downloaden. Cursusoverzicht – Voorjaar 2017 In het voorjaar 2017 bieden wij de volgende cursussen aan via open inschrijving ISO 13485:2016 – Wat is nieuw? Donderdag 16 februari Van MDD naar EU MDR Dinsdag 14 maart Implementatie Risicomanagement (EN ISO 14971:2012) Donderdag 30 maart Medische software – Verificatie & Validatie         Woensdag 12 april Deze en andere cursussen geven wij ook in-company

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Posted on 17, November 2016

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Quality & Regulatory Conference 2016 0

Mikrocentrum organises the Quality & Regulatory Conference on 24 November 2016 from 09.00 – 17.00, location *techniekhuys, Veldhoven. The Quality & Regulatory Conference addresses the practical implications of the ISO 13485:2016 as well as the major differences between the new MDR & IVDR. Leading experts in the medical device sector will provide you with tools, tips and inspiration that will help you in your daily business. Jeannette van Loon participates with a presentation on clinical evaluation according to the new MEDDEV 2.7/1 rev 4. For more information and registration please click on this link

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Posted on 3, November 2016

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ISO 13485:2016 – Wat is nieuw? 0

Een Gap analyse en plan van aanpak voor implementatie De ISO 13485:2016 norm is op veel plaatsen aangepast ten opzichte van de vorige versie. In deze cursus wordt u wegwijs gemaakt in de nieuwe ISO 13485:2016 norm en leert u hoe u de verschillen kunt verwerken in uw bestaande kwaliteitsmanagementsysteem. Ook zal worden ingegaan op de overeenkomsten en verschillen met ISO 9001:2015, die een andere structuur heeft, en hoe u daar praktisch mee om kunt gaan in uw kwaliteitsmanagementsysteem. Let op: De focus van deze cursus is op de verschillen met de vorige versie en niet op een volledige behandeling [&hellip

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Posted on 9, September 2016

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2-Days seminar on ISO 13485:2016 and EU MDR 0

Coming up: Bioforum, Israel’s leading center for applied knowledge, providing training and education activities to the biomedical, pharmaceutical and medical device industries, offers a 2-days seminar on the new ISO 13485:2016 and EU Medical Device Regulation. The objective of this seminar is to update on the changes made to ISO 13485 and to discuss the proposal text of the European Medical Device Regulation. Lecturer: Robert van Boxtel Date: 13 and 14 december 2016 Location: Dan Accadia Herzliya Hotel, Herzliya, Israel. For more information please click on this link

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Posted on 9, September 2016

in Category ISO 13485 2016

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MDProject Cursusgids Najaar 2016 0

De MDProject cursusgids najaar 2016 is nu beschikbaar, download hem hier. Cursusoverzicht – Najaar 2016 In het najaar 2016 bieden wij de volgende cursussen aan via open inschrijving: – ISO 13485:2016 – Wat is nieuw? Woensdag 12 oktober – Kwaliteitssysteem volgens ISO 13485:2016 Woensdag 21 en 28 september (2 dagen) – Risicomanagement (EN ISO 14971:2012) Donderdag 3 november – “Non-device” software validatie Woensdag 9 november – Interne audits op basis van ISO 13485 Woensdag 16 november – Medische software – Verificatie & Validatie Dinsdag 6 december Deze en andere cursussen geven wij ook in-company. In de cursusgids staat vermeld hoe u [&hellip

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Posted on 5, June 2016

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