Clinical Affairs

Clinical data provides evidence of the safety and performance of a medical device and is a critical factor throughout the product lifecycle. During the development and successful launch of medical devices, the fulfillment of basic safety and performance requirements plays an essential role. With the entry into force of the Medical Devices Regulation 2017/745, these requirements have increased enormously and pose a challenge to all medical device manufacturers.

The Clinical Evaluation Report, also according to current legislation, is a substantial part of the technical documentation, which has significant influence on the approval and certification. The core of the clinical evaluation is based on preclinical, especially clinical data that support the safety, performance and clinical benefit of the medical device. Clinical data can be obtained from clinical investigations, scientific literature or clinical experience data. If there is no sufficient clinical data prior to marketing approval, a Clinical Investigation must be performed to generate significant data for the corresponding product. Long-term performance and safety related data can be obtained product-specifically after market entry from Post-Market Clinical Follow-up. These can reveal new risks, provide valuable data on the assessment of risk-benefit ratio and check the appropriateness of the intended use. In addition to clinical data, preclinical data may also be used. These can be generated by own tests or analyzed and evaluated on the base of a Literature Search of Preclinical Data.

NSF PROSYSTEM GmbH offers several years of experience in the field of clinical affairs. Our quality management system is certified according to ISO 9001 and ISO 13485. We ensure regulatory compliance for the creation and update of your clinical evaluation, thereby accelerating the market entry and certification of your medical device. If the data are insufficient, a clinical investigation will be necessary. From the planning of your clinical study to the implementation to the evaluation, we support you with individual services or a full service package. Review and update of your post-market surveillance data is also covered by our portfolio. In addition, we can conduct individual literature searches for your documentation according to your requirements, e.g. in the form of biological safety reports under ISO-10993 and ISO 14971.

For more info on “Clinical Affairs” or for a quotation please contact us.