News

08/18/2020

Book release "Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation"

After months of work it is finally done!

This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking.

One of the authors is Brigitte Raffeiner, PMSc., who has many years of experience in the handling of clinical studies.

The book can be ordered now at: https://www.bod.de/buchshop/clinical-evaluation-and-investigation-of-medical-devices-under-the-new-eu-regulation-wolfgang-ecker-9783751937665

07/28/2020

Publication "Monitoring clinical studies in the age of digitalization" by Brigitte Raffeiner

Several pages of the 06/20 magazine of PHARMIND revolve around the topic "Monitoring of clinical studies in the era of digitalization". They could count on the broad knowledge of Brigitte Raffeiner. You can find an excerpt of the article at: https://www.ecv.de/beitrag/pharmind/Monitoring_klinischer_Studien_im_Zeitalter_der_Digitalisierung

07/02/2020

ISO 9001:2015 audit successfully passed!

On July 02, 2020 Mag. Andreas Raffeiner GmbH successfully passed the ISO 9001:2015 surveillance audit. The ISO certification has now been extended for another 3 years!

09/23/2019

Raffeiner sets an example for climate protection

On 27 September 2019, the "Fridays for Future" movement is calling on all people to join the cross-generational Earth Strike. Together they want to set an example for responsible climate and environmental policy!

Employer* and employee* involvement Fridays For Future activists stress that on 27 September 2019 workers should also take part in the protests. Many companies will therefore close their offices, shops and online shops either all day or during the strike to draw attention to the climate crisis and allow employees to participate in the Earth Strike.

Acting is not just talking: Our company has also thought about how we can participate meaningfully in this campaign. The obligation to preserve an environment worth living in for future generations is very important to us. Now we cannot and will not oblige you to take part in these strikes, of course, but:

We thought that we would release this working day to all of you who want to make a statement on Friday and want to take part in Earth Strike with a campaign (no matter if you want to take part in Earth Strike or just want to set a climate-friendly course of action).

08/05/2019

A new staff member

Khasbulat Emiyev joined our team on August 05th, 2019 in the office management.

08/05/2019

A new staff member

Raffaela Fötschl, BSc. MA joined our team on August 05th, 2019 as a project manager and CRA.

05/31/2019

New employee

Adelheid Puffing joined our team on May 31th, 2019 as a project manager and CRA.

03/15/2019

New employee

Sarah Bischof, BSc. joined our team on March 15th, 2019 as a project manager and CRA.

03/07/2019

New employee

Kerstin Resch, BSc. joined our team on March 1th, 2019 as a project manager and CRA.

05/15/2018

Certificate:Quality Auditor for Medical Devices

Mag. Andreas Raffeiner participated on 15th of May 2018 the Upgrade for Quality Auditor for Medical Devices and attended it with very high degree of success.

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