Your partner for clinical investigations & evaluations
Your Reliable CRO Partner for Medical Devices and IVD
CERES helps you as a medical device or in vitro diagnostic (IVD) manufacturer gain and maintain access to the European market. As a full-service Contract Research Organisation (CRO), we specialise in clinical trials and clinical evaluations for medical devices, and in performance studies and evaluations for IVDs.
Why CERES?
Because Experience and Trust
Make all the Difference
The regulatory requirements for manufacturers of medical devices and IVD are extensive and complex. With CERES at your side, you will be guided safely through all steps of a clinical investigation.
Our experts from the fields of medicine, science and engineering have decades of experience in planning, conducting and documenting clinical investigations. We know what is important – from the initial idea to successful CE marking and beyond.
Our experts from the fields of medicine, science and engineering have decades of experience in planning, conducting and documenting clinical investigations. We know what is important – from the initial idea to successful CE marking and beyond.
-
Excellence
Our in-depth knowledge and experience from countless projects guarantee the highest quality in every phase. -
Experience
Our team of scientists, engineers and physicians have long-standing experience in clinical investigations and evaluations and regulatory processes. -
Reliability
Clear communication, transparent processes and consistently on-time implementation allow planning security. -
Customisation
From start-ups to global companies – we offer customised solutions tailored to your individual needs.
-
Partnership
Successful collaboration is based on genuine trust. As a reliable and committed partner at eye level, we support you at every step.
-
Efficiency
We reduce complexity, get to the heart of your needs and develop practical solutions that save time and resources.
Clinical Product Lifecycle
Your Partner for Every Phase
As a CRO for medical devices and IVD, we are at your side at every stage – from product development to market launch, penetration and surveillance.
Our structured approach ensures efficient implementation: we analyse your needs, plan clinical trials in a targeted manner and conduct them in accordance with the highest standards. Our assessments and measures support you both in the conformity assessment and in post-market surveillance.
Benefit from our experience.
Our structured approach ensures efficient implementation: we analyse your needs, plan clinical trials in a targeted manner and conduct them in accordance with the highest standards. Our assessments and measures support you both in the conformity assessment and in post-market surveillance.
Benefit from our experience.
Event Calendar
28
JAN.
90 Min. – WEBINAR: Observational PMCF Studies
28.01
– 28.01.2026
, from 10:30 until 12:00 h
Our medical writers and clinical affairs managers from the sciences and medicine have years of experience in observational trials. In several webinar presentations on a variety of aspects of observational trials, they will give you valuable information from daily practice. As a full-service CRO, we plan, set up, execute and evaluate observational trials. Participate free of charge in this webinar and benefit from our experts‘ collective knowledge. We are happy to support you with your observational trials and other clinical investigations across the entire clinical product lifecycle.
Read more
Full-Service CRO
Customised Solutions for Every Phase
of Your Product
Our services are aimed at both established medical device and IVD manufacturers and ambitious start-ups entering this market. The MDR (Medical Device Regulation, EU Regulation 2017/745) and IVDR (In Vitro Diagnostic Regulation, EU Regulation 2017/746) place high demands on all players in the development and marketing of medical devices and IVD.
We support you in every phase of your product.
We support you in every phase of your product.
Overview
Clinical Investigations
Whether in the pre-market or the post-market phase – a clinical investigation can be useful across all different product life cycle stages. We plan and execute the different investigation designs in accordance with the respective stage of your medical device in the clinical product life cycle: exploratory, confirmatory or observational. Our core skills encompass the capability of providing the carefree package of all the different clinical investigation types: first in human, feasibility, pivotal, post-market observation, registry, interventional or non-interventional investigations. Included in our full-service clinical investigation package are project management, medical writing services, the statistical analysis plan and report, data management, monitoring as well as vigilance and safety. If you do not need the whole clinical investigation package, book our modular service individually. We take charge of your current situation – whether you need to obtain or maintain market access. We are your strategic partner at eye level.
Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.
Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.
Overview
Medical Writing
Our medical writing team of scientists, engineers and physicians
engineers and physicians prepare all important documents for clinical
trials – from from SOTA assessments, CEPs and CERs to CIPs, PICs and IBs.
We ensure MDR compliance and keep up to date with regulatory changes.
engineers and physicians prepare all important documents for clinical
trials – from from SOTA assessments, CEPs and CERs to CIPs, PICs and IBs.
We ensure MDR compliance and keep up to date with regulatory changes.
Overview
In vitro Diagnostics (IVD)
Regardless of the risk class of your IVD product, our experienced team of scientists, engineers and physicians takes charge of your needs.
If you are in the process of obtaining CE marking for your IVD, we will identify previously collected data on your IVD for you and its clinical performance for its intended use.
Through targeted analysis and strategic consulting, we help you leverage existing evidence efficiently. This not only saves time but also strengthens your overall documentation.
If you are in the process of obtaining CE marking for your IVD, we will identify previously collected data on your IVD for you and its clinical performance for its intended use.
Through targeted analysis and strategic consulting, we help you leverage existing evidence efficiently. This not only saves time but also strengthens your overall documentation.
Overview
Consulting
As a full-service CRO, CERES has decades of experience.
The collective in-depth consulting capabilities grant you access to this vast experience. We are happy to advise you on the most efficient clinical and regulatory strategy you need for your medical device or IVD product. Our focus is on your effective needs, not on our profit. Combine the profound consulting service with the subsequent services CERES has to offer and benefit from a carefree package from a single source. With CERES, you can form a strategic partnership at eye level. Our staff of scientists, engineers and medical doctors navigate you safely through the pitfalls of obtaining product approval and accessing the EU market.
The collective in-depth consulting capabilities grant you access to this vast experience. We are happy to advise you on the most efficient clinical and regulatory strategy you need for your medical device or IVD product. Our focus is on your effective needs, not on our profit. Combine the profound consulting service with the subsequent services CERES has to offer and benefit from a carefree package from a single source. With CERES, you can form a strategic partnership at eye level. Our staff of scientists, engineers and medical doctors navigate you safely through the pitfalls of obtaining product approval and accessing the EU market.
Packages
From Intro to Carefree Package
Take full advantage of our interdisciplinary medical writing team.
As a full-service CRO specialised in medical devices and IVD, we are your qualified partner for individual tasks or entire international multicenter studies. From the idea to collecting clinical data, through project management, to the final report and beyond.
As a full-service CRO specialised in medical devices and IVD, we are your qualified partner for individual tasks or entire international multicenter studies. From the idea to collecting clinical data, through project management, to the final report and beyond.
Large
With the most comprehensive package of CERES services,
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
Medium
The medium-sized package is aimed at manufacturers of
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
Small
The small package is our basic package for manufacturers
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
Intro
You are not quite sure what your next steps are, or whether
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.
Your Shortcut
to a Clear Strategy
I am Ute Meier-Weiger, your direct contact for all questions about our packages and services.
Whether you need an initial assessment or would like detailed information, I will be happy to support you and pass your enquiry on to the expert in charge.
Whether you need an initial assessment or would like detailed information, I will be happy to support you and pass your enquiry on to the expert in charge.
Ute Meier-Weiger
Customer service
Times:
Monday to Friday from 9:00 a.m. to 5:00 p.m.
