Medizinprodukten. Erfahren Sie Neues zu regulatorischen Anforderungen und
Best Practices – prägnant, verständlich und praxisnah.
Klinische Prüfungen
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.
Medical Writing
Unser Medical Writing Team aus Wissenschaftlern, Ingenieuren und
Medizinern erstellt alle wichtigen Dokumente für klinische Prüfungen von SOTA-Bewertungen über CEP und CER bis hin zu CIP, PIC und IB. Wir gewährleisten MDR-Konformität und halten uns stets über regulatorische Änderungen auf dem Laufenden.
- Services
- Medical Writing im Überblick
- Klinischer Bewertungsplan (CEP)
- Klinischer Entwicklungsplan (CDP)
- Literaturrecherche
- Klinische Bewertung (CER)
- Post-Market Clinical Follow-Up (PMCF) Plan u. Report
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Prüfplan (CIP)
- Patienteninformation u. Einwilligung (PIC)
- Prüferbroschüre (IB)
- Klinischer Prüfbericht (CIR)
In-vitro-Diagnostika (IVD)
Benötigen Sie eine Leistungsprüfung für Ihr IVD?
Möchten Sie Ihre medizintechnische Lösung unter kontrollierten
Bedingungen anwenden und verbessern?
Wir unterstützen Ihren Zugang zum Europäischen Markt.
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.
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.
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Profil CERES
Sehen Sie hier, für welche
Werte die CERES steht und
wer CERES ist. -
Karriere
Finden Sie hier nähere Infos
zu offenen Stellen und zu
den Vorteilen der CERES. -
Testimonials
Lesen Sie hier über Erfolgsgeschichten und Kundenstimmen.
Erfahren Sie, was unsere Kunden überzeugt hat.