Scientific Writing for In Vitro Diagnostic Manufacturers –
Why Professional Support in Writing Scientific Documents for Technical Documentation Is Helpful
The pressure is growing: IVD manufacturers in focus
With the introduction of the IVDR, the regulatory requirements for in vitro diagnostics (IVDs) have significantly increased. Manufacturers are increasingly faced with the challenge of preparing complex technical and scientific documentation on time and to a high standard. Especially in the area of clinical and scientific evaluation, the workload is immense, while internal resources are often limited.
Professional scientific writing can make a decisive difference here and greatly ease the path to successful conformity assessment.
What is scientific writing?
Scientific writing in a regulated environment encompasses far more than just drafting texts. It involves structuring scientific data, study results, and technical information in a clear, transparent, and regulatory-compliant manner. The focus is on the transparent presentation of scientific evidence that meets the requirements of regulatory reviews. For IVD manufacturers, performance evaluation is of central importance, with three key documents playing a crucial role: the Scientific Validity Report, the Analytical Performance Report, and the Clinical Performance Report.
The Scientific Validity Report: challenges and solutions
The Scientific Validity Report (SVR) is one of the three pillars on which performance evaluation under Annex XIII of the IVDR is based. It documents the scientific basis for why a analyte is clinically relevant – in other words, demonstrating that a detected biomarker is clinically meaningful. However, there are often challenges:
- Which literature is relevant, and how deep should the research go?
- How do you structure the report so that it is stringent and auditable while keeping the scope appropriate?
- How do you clearly differentiate the content from the Analytical and Clinical Performance Reports, as well as the state-of-the-art?
The SVR is often underestimated; it is not just a required document but also a strategic document with significant weight in audits.
Our services: Your partner in scientific writing
We specifically support IVD manufacturers in the preparation of regulatory documents – scientifically rigorous, linguistically precise, and compliant with applicable regulations. Our expertise includes:
- Full preparation of Scientific Validity Reports (also offered as a “standalone” service)
- Systematic literature review (e.g., PICO methodology)
- Critical appraisal of scientific publications
- Coordination with your existing Performance Evaluation Plans
- Integration of the latest MDCG guidelines and ISO 20916
Our team combines scientific expertise, regulatory knowledge, and years of experience in the field of in vitro diagnostics.
Your Benefits as a Manufacturer
- Time and cost savings through external support
- Minimized risk during audits and reviews
- High-quality text and structured argumentation
Fresh perspectives from an external viewpoint in your documentation process
Conclusion: Scientific writing is more than just documentation –
it’s strategy
A strong Scientific Validity Report is not just bureaucratic paperwork; it is a key component of your success strategy. With a professional partner by your side, you ensure that your documentation meets the high standards of the IVDR while also demonstrating the scientific value of your product.
Don’t hesitate! Let us tackle your challenges in the field of scientific writing together. Contact us today!
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