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Medical Devices

Our services for your medical devices

novineon CRO supports your medical device through all phases of its life cycle:  from usability and clinical evaluation to post-market surveillance and to the next round with your enhanced successor product.

In vitro Diagnostics

Our services for your in vitro diagnostic medical devices

novineon CRO structures your technical documentation of the performance evaluation of your in vitro diagnostic medical devices: from the review of the risk analysis and instructions for use to the preparation of the plan and report of the performance evaluation and post-market surveillance.

Contact

+49 7071 98979 – 126
RA@ remove-this.novineon.com

Careful design verification and validation prior to market launch is important for high quality medical devices. Good pre-clinical planning can save time and costs during conformity assessment. In addition to many technical requirements and specifications, the usability of the medical device should be taken into account at an early stage.

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Contact

+49 7071 98979 – 126
RA@ remove-this.novineon.com

Contact

+49 7071 98979 - 139
studies@ remove-this.novineon.com

There is a suitable methodology for every question or product – be it a clinical study, clinical trial, register study, post-market surveillance or a user questionnaire.  Regardless of whether you are in the planning phase or have already started a study, we will support you.  Together we can also clarify whether your own clinical data are sufficient or whether there is a need for a (further) study.

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Contact

+49 7071 98979 - 139
studies@ remove-this.novineon.com

Contact

+49 7071 98979 – 124
CER@ remove-this.novineon.com

Based on two decades of experience, novineon CRO supports manufacturers in the clinical evaluation of their medical devices. We prepare the documents necessary for clinical evaluation and advise you in questions of strategy and implementation.

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Contact

+49 7071 98979 – 124
CER@ remove-this.novineon.com

Contact

+49 7071 98979 – 126
RA@ remove-this.novineon.com

It is a great challenge to prepare and update the  numerous documents for conformity assessment, including the technical documentation and quality management. We would like to work with you to meet this important challenge. We support you in risk analysis, developing instructions for use, biological evaluation and conformity assessment in international markets.

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Contact

+49 7071 98979 – 126
RA@ remove-this.novineon.com

Contact

+49 7071 98979 – 127
pms@ remove-this.novineon.com

There has been a demand for suitable PMS/PMCF strategies since the MDR has been valid, even for "established products" that are still certified according to the former directive.  Therefore, manufacturers need to act now, even if "post-market monitoring" issues are gladly postponed to "post-market launch".

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Contact

+49 7071 98979 – 127
pms@ remove-this.novineon.com

Contact

+49 7071 98979 – 128
ivd@ remove-this.novineon.com

Performance evaluation is the main document that shows clinical evidence of your in vitro diagnostic medical device. This evidence mainly contains scientific validity, analytical performance and clinical performance. Additionally, data from risk management and post-market surveillance are taken into account.

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Contact

+49 7071 98979 – 128
ivd@ remove-this.novineon.com

Contact

+49 7071 98979 – 129
ivd@ remove-this.novineon.com

The safety and performance of your in vitro diagnostic medical device must be verified regularly. For this purpose, risks are assessed in a risk analysis and explained to the user in the instructions for use. Both documents are continuously updated through post-market surveillance and includedin the performance evaluation.

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Contact

+49 7071 98979 – 129
ivd@ remove-this.novineon.com

novineon CRO

Your product and our experience in clinical and regulatory affairs –
We level your path to CE conformity and beyond.