About Us

Clinical research for medical devices, since 2005.

As a contract research organization (CRO), CERES can help you solve your problems and meet your goals, both before and after demonstrating CE conformity. We offer complete clinical trial management for medical devices, as well as just the help you need to succeed. We can fulfill the ongoing regulatory responsibilities necessary to gain and maintain your CE mark. We also perform market surveillance via Post-Market Clinical Follow-up (PMCF) studies. All of our services can be customized to fit your needs.


2005

In 2005, Dr. Stephan Joeken founded CERES, foreseeing increasing requirements for clinical trials on medical devices in Europe.

2007

Since 2007, clinical trials on medical devices have been required: The European Directive for Medical Devices 2007/47/EC was written to amend the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMD).

2008

In 2008, we introduced our exclusive online data-capturing system, “aTRIAL”. aTRIAL ➚  facilitates qualified electronic capture of clinical trial data, and supports Case Report Form (CRF) handling, monitoring, and reporting. aTRIAL is efficient, and significantly reduces the time necessary for, and cost of, data collection. Our customers choose between collecting clinical data on paper, or via aTRIAL.

2010

In 2010, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies,” MEDDEV 2.7/1 rev. 3, by the European Commission on Cosmetics and Medical Devices, took effect, amending Directive 2007/47/EC. These guidelines described a required periodic clinical evaluation for medical devices by either literature review demonstrating substantial equivalence to CE-approved medical devices for which adequate clinical-trial data already exist, or conducting clinical trials. Other relevant regulatory changes have addressed software, disposables and their re-use, implantable devices, manufacturer’s specifications, and instructions for use.

2012

Our next generation data-capturing system, “aTRIAL” was released. aTRIAL ➚  V2 facilitates qualified electronic capture of clinical trial data, and supports handling of individual Case Report Forms (CRFs), monitoring, and reporting.

We support the national strategy process Innovations in medical technology “Innovationen in der Medizintechnik” for medical technology and actively showed the opportunities of a proactive PMCF. The process was organized by the Federal Ministry of Economics in cooperation with the Federal Ministry of Research and Federal Ministry of Health.

2016

In June 2016, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies,” MEDDEV 2.7/1 rev. 4 ➚, by the European Commission on Cosmetics and Medical Devices, took effect. These guidelines described a required periodic clinical evaluation for medical devices by either literature review demonstrating substantial equivalence to CE-approved medical devices for which adequate clinical-trial data already exist, or conducting clinical trials. Other relevant regulatory changes have addressed software, disposables and their re-use, implantable devices, manufacturer’s specifications, and instructions for use.

2017

On April 5, 2017, the EU Parliament passed the new Medical Device Regulation (MDR). With a few exceptions, the regulation on medical devices will apply from 26 May 2021, i.e. after the extended transition period.

Smaller and medium-sized companies are potentially hit particularly hard by the demanding new clinical requirements and the extensive documentation and reporting requirements due to lower staffing and funding opportunities. Regulatory compliance can force some medical device manufacturers to take drastic steps.

The transition will result in a medical technology industry that is significantly different from today’s.

Many companies have started to address the challenges and realized that the changes require an enterprise-wide approach. These companies have recognized that MDR is not only a compliance challenge, but also an opportunity to add value to the business at this time.

2019

We have moved to our new premises. On the one hand, we did justice to our steady growth. In particular, however, it was foreseeable that the upcoming MDR-related changes would require further resources.

2021

The MDR comes into force on May 26th. As your CRO for medical devices, CERES implements its services according to the latest regulations so that the needs of manufacturers can be efficiently supported during the changes and in MDR-compliant projects.


At CERES, our comprehensive understanding of these past and potential regulatory changes, and our proactive project management style have lead to our success. Esprecially for long-term clinical trials, early consideration of regulatory changes is important.

CERES has performed clinical studies in several European nations, and has achieved CE approval for numerous medical devices via literature-based clinical evaluations. As we proceed together into the future, both our employees and management thank all of our customers for their confidence in our ability to meet their ongoing needs.

In the future, we hope to share our success with you.