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Qmed Consulting Newsletter / October 2016
Clinical Evaluation Report (CER) MDD 93/42/EEC and MEDDEV 2.7/1 ver. 4 Compliance

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. Download the free .pdf guide now:

CER Brochure
New requirements for your CER
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 consequently 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.

How do you comply with the new requirements in the rev 4 version of the MEDDEV for your clinical evaluation report? At Qmed Consulting we are always up to date with the latest changes and demands. Let us help you update your CER writing process:
Qmed Consulting: 10 years in business, now transformed to A/S
Qmed Consulting has been in business for 10 years. And what a ride! From one single employee ten years ago to the 18 dedicated people today, both in Denmark and abroad. And with a brand new business developer on board November 1st, we are able to continue further growth of the company.

The anniversary was celebrated with employees, family and friends on the most beautiful day in Copenhagen at The Standard’s Jazz Club, where the activities for 2016-2017 were planned in inspiring surroundings of Copenhagen Harbour, portending a promising future for Qmed Consulting.

The future already started a week later on September 15th, when Qmed Consulting was converted from ApS (Private Limited Company) to A/S (Public Limited Company). After the conversion, the share capital was raised from T.DKK 125 to T.DKK 1.000 and a professional Board was elected.

The Board consists of one company representative Director and CFO Mikael Møller and two board members: Chairman Agnes Friese Skov, Direct Marketing Manager at Oticon, and Vice Chairman Charlotte Bruun Piester, self-employed Management Consultant with more than 20 years of experience within the medical device world – to help increase growth of the company and boost development in current as well as new areas.
Meet up with us at the annual TCT Participation in Washington
Qmed Consulting will be joining the TCT Participation at The Washington Convention Centre in Washington DC from October 31st to November 2nd 2016. We will be looking forward to some exciting moments with both colleagues and leading experts in interventional cardiovascular medicine, and hope to meet existing as well as new customers. Come join us for this extraordinary event and feel free to contact us for an informal meeting.

Contact us
New forces – new employees
Are you our new employee? Qmed Consulting is in tremendous growth and we are looking for new colleagues to join our team. Please see our Careers page for open positions:

At Qmed Consulting we strive to provide the best service possible in order to pave the way for new medical device approvals that both allows more efficient procedures and improves and secures the safety of patients and their quality of life.

Therefore, we are always looking for qualified employees with the right experience and competences and are very happy to welcome the newest members of the Qmed team:

Pernille Veje, QA manager
Pernille has over 15 years of medical device industry experience within regulatory affairs and quality assurance. She has worked with quality management systems, strategies and implementation of related activities including change management and working with various stakeholders and cultures.

Her previous work includes Medical Device legislation, and product compliance in a global perspective with multiple manufacturing sites; design, development and manufacturing control including design & technology transfer to low cost areas; regulatory affairs and product registration in collaboration with international industry and agencies (EU: CE-marking, US: 510(k), Canada, Japan, China and ROW).

Jacqueline Fransen, CPM and lead CRA
Jacqueline has 16 years of experience within the Medical Device Industry. She holds a bachelor degree and has worked for 10 years for a pharmaceutical/medical device company and CRO. She has worked as research coordinator in several specialized thorax centers in the Netherlands. Her previous work includes cardiovascular surgery, vascular surgery (below the knee), interventional cardiology, valve surgery and rhythm device studies. She speaks Dutch (native speaker), English and German on a daily basis.

Carri Brown, Lead CRA
Carri Browne has over 20 years of experience in the Clinical Research Industry. After graduating with a Bachelor of Science degree in Biology she spent time at Johns Hopkins University working on a degree in Biotechnology. Most recently, she spent 10 years working for a leading Cardiac Medical Device company Boston Scientific Inc as a Lead Principal CRA. Prior to this, she worked in the Pharmaceutical industry with a focus in Oncology, Immunology, and Cardiology. During this time, she spent two years as an independent consultant providing clinical research services to many biotech and pharmaceutical corporations. Carri is an ACRP certified CRA.

Dorthe Almdahl-Scrøder, CRA
Dorthe is a registered nurse and has 13 years of experience within the fields of Neurology, Neonatal Care, Gastroenterology and Respiratory medicine from public hospitals. Dorthe has 8 years of experience within Pharmacovigilance and Global Development of Phase II-IV trials working for Novo Nordisk within haematology, diabetes and inflammation. She speaks fluent English and Danish and is proficient in German and French.

Visit the Qmed Consulting Team page
Director of Business Development & Sales to be announced
On November 1st 2016 we will be welcoming to the Qmed team our new Director of Business Development & Sales, a talented individual with a long history and background within the medical device, consultancy and CRO business. We look forward to introducing him to our clients and partners. The focus for the new director will be to support the ongoing business and growth of the company internationally.

From idea to revenue, Qmed Consulting is your partner for medical device CRO services.
Qmed Consulting ApS.
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