CERES GmbH evaluation & research
e-PMCF Solution by CERES
     
Targeted Collection of Clinical Data

Dear Business Partner,

Your own clinical data gain considerably in importance when the MDR enters into force. In the future, clinically relevant data for medical devices shall be collected and evaluated continuously. In particular Article 61 and Annex XIV of the MDR are to be taken into account, which in accordance with Article 10 (3) belong to the general obligations of manufacturers.

Post-Market Clinical Follow-up - proactively used

A successful PMCF-strategy enables you already today to pave the way for upcoming conformity assessment procedures or (re-)certifications. Clinical data with your own medical device, collected at the times of MDD/AIMD, can substantially facilitate or even enable future regulatory compliant clinical evaluations - before or after May 26th, 2020.

CERES offers you:

e-PMCF Solution

  • Continuous collection of device-specific clinical data on safety and performance
  • Design and online provisioning of appropriate questionnaires
  • Access to physicians, health care professionals and hospitals
  • Regular export of anonymised data for further analysis by the manufacturer or by CERES

Overview

  • Provision of the platform
  • Integration of customized product-specific questions
  • Up to 6 users, further users can be added on demand
  • Quarterly overview
  • Export of data
  • Term of validity: 6 months or more 

Ask for your individual offer here:

e-PMCF
   

Your Benefit

  • Collection of clinical data according MDR-requirements
  • Meeting the regulatory requirements while avoiding the principle of equivalence
  • The digital format enables easier processing of the data for the CER (Clinical Evaluation Report), PSUR and publication
  • Targeted clinical evaluation of your medical device
  • Access to your health care professionals
  • Cost- and resource-effective collection of the relevant data

Optional Services

  • Development of a strategy for market surveillance (PMS, PMCF and CEP)
  • Support in applications to ethic committees
  • Detailed evaluation and analysis of collected e-PMCF-data
  • Creating of the PSUR (Periodic Safety Update Report)
  • Writing of the SSCP (Summary of safety and Clinical Performance)


Attachment(s):
CERES_ShortProfile2019.pdf
     
 

CERES GmbH evaluation & research
Brombacher Str. 85, 79539 Lörrach, Germany


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