EU MDR is to be postponed by one year

The coronavirus pandemic presents all of us with unprecedented challenges. Over the next few weeks and months, the top priority for medical device companies must be producing the necessary products for medical care of the population in sufficient numbers in

READ MORE

Statement COVID-19

The corona virus pandemic is currently changing our entire professional and private lives drastically. For us as a company, the top priority is to protect the health of our employees while ensuring ongoing operations. For this reason, we have developed

READ MORE

Spenden statt schenken – unsere Weihnachtsspende 2019 (German)

Im Geschäftsjahr 2019 haben wir uns dazu entschieden, im Rahmen unserer Weihnachtsgrüße auf Grußkarten und Geschenke für unsere Kunden zu verzichten und wie bereits in vorangegangen Jahren eine Spende für gemeinnützige Zwecke zu tätigen. Dieses Jahr durften unsere Kunden mithilfe

READ MORE

1st phase of EUDAMED M2M testing mastered

Next to the China UDI pilot, we also participate in the closed EUDAMED M2M testing project and already mastered the 1st phase successfully. We operate our own access point which communicates directly with the EUDAMED database. With this we have

READ MORE

First Update: China UDI Pilot

As already mentioned in October, we are taking part in NMPA’s UDI pilot phase. This is our progress so far: In order to take part in this pilot project, we created a new Content Package especially for China. After thorough

READ MORE

1st EUDAMED Go-live

We are proud to announce that our first EUDAMED project for UDI Platform with a world-leading medical device manufacturer had its first Go-live recently. The implementation based on preconfigured content was possible within 6 weeks. Thanks to the integration of

READ MORE

Why UDI is still important for EU MDR despite EUDAMED delay

As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Therefore there is no

READ MORE

Delay of EUDAMED

As you may have already heard, the European Commission stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Read the official statement. Nevertheless, the date of application of the EU

READ MORE

SAP S/4HANA Webkonferenz für die Life Sciences am 14. November 2019 (German)

Am Donnerstag, 14. November 2019 veranstalten SAP Deutschland, DHC und projektraum36 eine SAP Life Sciences Webkonferenz zum Thema „Optimierung von Prozessen im Pharma und Medizintechnik Mittelstand mittels SAP Best Practice Lösungen (Model Company) On-Premise und in der Cloud.“ Thema der

READ MORE

China UDI pilot

From July 2019 to June 2020, NMPA is running an UDI pilot to verify the functionality of its UDI database. The go-live of Chinese UDI database is planned with the date of application for implantable devices on October 1st 2020.

READ MORE