Clinical Affairs

Fulfilling basic safety and performance requirements is essential beyond the development and successful launch of a medical device. Clinical data is essential to demonstrate safety and performance throughout the lifecycle. With Regulation (EU) 2017/745 (MDR, Medical Device Regulation), these requirements have increased enormously.

Sources of Clinical Data as Part of a Clinical Evaluation

The clinical evaluation is, even under current legislation, a substantial part of the technical documentation, which is crucial for approval and certification. Clinical data can be obtained from clinical investigations, scientific literature or empirical data. If not enough clinical data is available prior to market approval, a clinical investigation must be performed to generate meaningful data for the corresponding product. Long-term performance and safety data may be product-specific after market entry, e.g. obtained from post-market clinical follow-up. These can reveal new risks, provide valuable data for the reasonableness of the benefit-risk ratio and check the appropriateness of the purpose. In addition to clinical data, preclinical data can also be used. These can be generated by our own tests or analyzed and evaluated based on a literature search of preclinical data.

We have years of expertise in the field of clinical affairs. Our quality management system is certified to ISO 9001:2015. Our experts have experience in the analysis and assessment of existing preclinical and clinical data, and also assist in the generation of data. We conduct specific literature searches in relevant databases (e.g. MEDLINE via Pubmed, Embase, Cochrane Library or TOXNET) and offer individual clinical investigation services. We accompany clinical investigations according to specific needs or as a full service from planning through implementation to evaluation. After your product is placed on the market, we can review and monitor your market data. As part of medical writing, we document the data for your product in a clinical evaluation, a biological safety report, a post-market clinical follow-up report or other medical-scientific texts. We ensure regulatory compliance for the creation and updating of your documentation to accelerate market entry and certification of your medical device.

Medical writing services:

  • Conducting and updating clinical evaluation reports (CERs) according to MEDDEV 2.7/1 Revision 4, Regulation (EU) 2017/745 or NMPA (formerly CFDA) requirements
  • Creating and updating biological safety reports (BSERs) according to EN ISO 10993 and EN ISO 14971
  • Creating topic-specific summaries after conducting literature research to obtain preclinical and clinical data
  • Producing documents for clinical investigations under EN ISO 14155
    • CIP, clinical investigation plan
    • CIR, clinical investigation report
    • CRF, case report form
    • IB, investigator’s brochure
    • ICF, informed consent form
  • Creating post-market clinical follow-up plans and reports (PMCFs)
  • Creating and updating post-market surveillance reports (Article 85 Regulation (EU) 2017/745 post-market surveillance report) and PSUR (periodic safety update reports) according to Article 86 of Regulation (EU) 2017/745)
  • Creating scientific publication manuscripts (after CONSORT, STROBE, etc.)

For further details on “Clinical Affairs” or for a non-binding offer please contact us.