Lunde - Clinical Studies for Medical Devices - Germany

Summary

Hi - I'm an American working for CERES GmbH evaluation & research in southwest Germany.

We run European clinical studies for medical devices, and write literature-based clinical evaluations for medical devices that are very successful at achieving CE approval.

Please visit our website at www.clinical-evaluation.com
This is a German company - click on the US/UK flag on the homepage for English.

As a full-service contract research organization solely focused on providing clinical trials and evaluations for medical devices, CERES can help you access the European market, running your whole study or providing just the help you need to succeed.

Our clinical trials enable you to:
• explore device feasibility
• gain first-in-human experience
• gather post-market clinical follow-up data
• collect market research
• support your application for CE approval

CERES employs scientists, statisticians, and clinicians with years of international experience. In cooperation with physicians in several European nations, we conduct successful clinical studies and conclusive clinical evaluations for medical devices.

Customers with CERES are members of the global medical device community. Our range includes most medical and surgical fields, such as electrophysiology and cardiology, surgery, neurology, neurosurgery, and vascular surgery, among others. Although we work with some global companies, most of our customers are mid-sized medical device manufacturers with 20 to 200 employees.

Services

Clinical Studies for Medical Devices

Summary:

With CERES GmbH evaluation & research in southwest Germany, I'm offering clinical studies for medical devices. We can run your whole study or provide just the help you need to succeed.

Work History

Research, Sales, and Marketing

CERES GmbH evaluation & research

From November 2011

For CERES, I sell European clinical studies for medical devices, and litertaure-based clinical evaluations for medical devices that are very successful at achieving CE approval.

Projects

Proposed European Medical Device Regulation

Proposed EU medical device regulations could change the way in which CE approval is gained for high-risk medical devices. Clinical trials of these items would be required and post-market clinical follow-up – with third-party, or external-expert review – necessary to maintain approval of class-III devices. What else might the proposals mean, and how should manufacturers adapt? Dr Karen Lunde from CERES investigates.

The ‘Proposal for a Regulation of the European Parliament and of the Council on Medical Devices’ in 2012 was prompted in part by a series of implant-related scandals. The most promiment of these concerned French company, Poly Implant Prothèse (PIP), when EU authorities discovered that it had been using industrial, rather than medical-grade, silicone in its CE-approved breast implants since 2001.

With EU action pending, the proposal, as amended, outlines new requirements for achieving and maintaining CE approval for ‘high-risk’ devices. The proposed amendments are shown as italics in this article.

The 2012 proposal can be downloaded, free of charge, from the website of the European Commission (ec.europa.eu). The 2013 amendments can also be found online (search for “amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices”).

Qualifications & Certifications

Biology (PhD)

University of California, San Diego

Medicine (3.5 years toward an MD, no degree)

University of Iowa

Biochemistry (BA)

University of Iowa

Ankeny High School

Biomedical Engineering (BS)

University of Iowa

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