CER

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Services

Training for the Clinical Evaluation

It is required that authors and evaluators are sufficiently qualified to perform clinical evaluation and write Clinical Evaluation Reports. Departments that have interfaces to clinical evaluation must be trained to understand the requirements of Regulation (EU) 2017/745 and MEDDEV 2.7/1 revision 4. We provide individual in-house training and speak at seminars to get you and your colleagues up to speed in the field of clinical evaluation.

Report of the Clinical Evaluation

We support our clients during every phase in the process of a clinical evaluation.

  • Stage 0: plan the product specific clinical evaluation according to the requirements of MEDDEV 2.7/1 revision 4 and Regulation (EU) 2017/745
  • Stage 1: identify pertinent clinical and non-clinical data from the relevant sources
  • Stage 2: appraise the identified clinical data from clinical investigations as well as scientific literature and other sources
  • Stage 3: analyse the relevant data sets and build the body of evidence based on sufficient clinical data
  • Stage 4: compile the clinical evaluation report, summarizing the results of clinical evaluation in support of evidence of the general safety and performance requirements

As clinical evaluation is an ongoing process, we also offer the service of continuous updates of CERs based on new clinical data.

Additional Services

Expert Reviews

Clinical Evaluation must be performed by a team of qualified authors and evaluators. As many manufacturers lack the inhouse expertise to comply with the requirements, we offer our expert reviews of your clinical evaluations and complement your teams. Depending on the needs, we can either focus on the regulatory compliance review or on the medical review or both.

Clinical Evaluation Update Service

Depending on the medical device class and the device specifics (e.g. established device vs. high-tech innovation) the updates of the CER have to be performed regularly. We support our clients with regular updates without the need to think about it.

Gap-Analysis for the Clinical Evaluation

The gap analysis for clinical evaluations is intended to identify gaps in the process and in the individual clinical evaluations. A gap analysis can also be performed by yourself, but the advantage of commissioning the analysis is that the data can be viewed independently with “neutral glasses”.

After the gap analysis for your clinical evaluation, you will receive comprehensive documentation of any gaps. Depending on the extent and type of gaps, it may be necessary to update your CER or generate new clinical data. On the basis of the gap analysis, a revision plan can be created on request.

Process of the Clinical Evaluation

Clinical evaluation is a process and processes need to be described as part of the quality management system.

SOP Development

Clinical evaluation is a process and processes need to be described as part of the quality management system. We help you design your clinical evaluation process in accordance with MEDDEV 2.7/1 revision 4 and Regulation (EU) 2017/745. We also take care that your process ties in with product development, risk management, post market-surveillance and other related processes of your Quality System.

SOP review & update

Your existing SOPs for Clinical Evaluation may need an update to the new requirements of MDR and MEDDEV. We make sure that your processes are aligned and enable you to efficiently collect pre-clinical and clinical data for clinical evaluation

Post-Market Evaluation

The clinical evaluation must be proactively fed with data from post-market observation. Our services are aimed at establishing the post-market surveillance process, supporting the observation activities and helping our clients to produce the necessary reports.
PMS & PMCF Gap-Analysis & Planning

MDR calls for detailed PMS & PMCF activities. Our first step to help our clients is to perform a gap-analysis and have a look at the existing procedures. From there, we collaboratively develop MDR-compliant SOPs with our clients.

PMS as a Service

Market observation is a time consuming task, especially if performed pro-actively, not relying on complaints only. Our team has detective-like skills and provides you with a not-to-worry solution to cover your pro-active duties for market surveillance. Especially in the field of Post-market clinical follow-up, we support our clients to find slim solutions to efficiently gather as much data as necessary to grow the body of clinical data evidence that is sufficient to declare conformity.

PSUR, Post Market-Surveillance Reports

Regulation (EU) 2017/745 requires that all results and updates from market observation must be summarized into reports depending on the device class. We offer a helping hand to support our clients with these time consuming tasks and provide support with the compilation of the documentation necessary. We also make sure that the reports are taken into account in the continuous update of CERs.

Summary of Safety & Clinical Performance

For class IIb implantable products and class III products, SSCPs must be written and be made publicly available via EUDAMED. While EUDAMED might not be running by 2020-05-26, the requirement to make SSCPs publicly available remains. We help you write and update the Summaries and also provide the service of making the reports available in a centralized database.