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Qmed Consulting Newsletter / April 2017


How is MEDDEV 2.7.1 revision 4 changing the landscape for CER Report

Be sure not to miss this complimentary webinar on May 3, 2017. Places are limited so please register today.

CER Brochure
A new version of the European Guideline MEDDEV 2.7/1 rev 4 was issued in June 2016 affecting all companies that market medical devices in Europe.
The MEDDEV is a guidance document and therefore there is no implementation period. Therefore, it is important to start using the new version. The general principle in performing a clinical evaluation report remains the same. The manufacturer must use clinical data to demonstrate compliance with relevant Essential Requirements. Such data still has to be based on investigations done with the subject device and data from post-market surveillance (PMS) activities and vigilance activities where appropriate.

Download the free CER .pdf guide
Complimentary webinar May 3,2017:
How is MEDDEV 2.7.1 revision 4 changing the landscape for CER Report
The course will be delivered by Anette Kristiansen -Senior Clinical Research Associate & Principal Advisor.

Anette is experienced with clinical trials within the field of Airway Management, Cardiology, Diabetes, Neurology, HIV-AIDS and Anesthesia, Hemodynamics, drugs used for anesthesia, anesthesia and herbal medicine, perioperative fluid optimization. She has been developing clinical trials for preclinical testing in cadavers and the development of detail aids for marketing material. With Qmed, Anette is responsible for clinical study, regulatory submissions to Ethic Committees and Competent Authorities and as well as writing CER/Clinical Evidence reports.

Date: May 3, 2017
Presentation: 14:00-14:45 CET
Q&A: 14:45-15:00 CET

Places are limited so please register today.

New faces at Qmed Consulting
Inger Kühne – Clinical & Regulatory Affairs Senior Principal Advisor
Inger Kühne has over 20 years of experience with clinical investigations and regulatory affairs in the area of medical devices. She holds an MSc in Experimental Biology, Human Nutrition, from the University of Southern Denmark.

She has 7 years of experience from the medical device industry and 15 years of experience from the Competent Authority on medical devices and has worked in all areas of regulatory affairs from early development to post market surveillance of medical devices in all classes, including combination products, AIMD and IVD medical devices and has been the national representative on national and European working groups on medical devices, including Clinical Investigation and Evaluation WG, MDEG Vigilance, MDEG Borderline and Classification and has furthermore been involved in the surveillance and Joint Assessment of Notified Bodies.

Johanna Horppu -Regulatory Affairs and Quality Assurance Senior Principal Advisor
Johanna has over 15 years of hands-on experience within medical device and pharmaceutical regulatory affairs, from established to start-up companies as well as CRO/consultancy. She has been involved with a broad range of device classes and regulatory affairs activities in all stages of product life-cycle, including compiling registration applications within EU, US and ROW, handling pre- and post-market authority interactions and providing for regulatory intelligence and strategy during product development. She is also experienced in the development, implementation and maintenance of quality management systems, especially design controls. Johanna holds an M.Sc. in business, giving her a solid capability to work with both the commercial and the regulatory goals of the life-science businesses.

Mette Ørum Thun - Clinical Research Associate
Mette has 15 years of experience within the Clinical Research and the Pharma Industry. Her educational background is a master of science in Pharmacy from Copenhagen University. She has worked for both CROs and Pharma companies in the field of Clinical Research and Marketing. Mette has worked as a CRA and as a project manager with studies in phase II-IV.

Her previous work includes the cardiovascular area, HIV, Hepatitis, Immunology and Oncology. She speaks fluently Danish and English.

Katherine Holloway Petersen – Clinical Trial Assistant
Katherine’s educational background is a bachelor’s degree in nursing from Metropol Copenhagen. During her career as a nurse she has achieved specialized knowledge within the patient categories acute cardiac patientcare, orthopedic patientcare and dialysis patientcare. Her experience with medical devices and procedures is therefore from clinical practice in an evidence based environment. Working with constant new research literature and how this translates into practical medical settings has been an important part of her nursing practice.

She has strong organizational skills, focus on details and working in a diverse professional setting with focus on high quality solutions.

Visit the Qmed Consulting Team page
Qmed Consulting Exhibition stand at the Charing Cross Symposium (CX17) on the 25th - 28th April 2017
Olympia London, Hammersmith Road (entrance on Olympia Way), London, W14 8UX, United Kingdom

The Charing Cross Symposium (CX), first took place in 1978 at Charing Cross Hospital, Hammersmith, London and has by now become the longest running vascular and endovascular symposium in Europe and one of the largest in the world. Meet us at stand number 511 or pre-book a meeting.

Pre-book a meeting

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