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At Lorentis, we specialize in delivering high-quality medical and regulatory writing services exclusively for the medical device and in vitro diagnostics (IVD) industries. Our founders bring over 40 years of combined experience in medical writing and clinical operations, ensuring that your projects are handled with the utmost expertise and precision.
We truly understand the complexities of regulatory requirements and clinical documentation, and are committed to consistently deliver clear, accurate and compliant documents that drive your success.
Trust us to transform complex data into compelling narratives that resonate with regulators, clinicians, and stakeholders alike.
In an industry where regulations are constantly evolving and the stakes are high, the need for specialized medical writers has never been greater.
At Lorentis, we understand these challenges and are here to help you navigate them with expertise and precision.
The medical device and IVD industries are subject to stringent regulatory standards set by the EU medical devices (MDR) and in vitro diagnostics regulations (IVDR) in Europe and by the FDA (Food and Drug Administration) in the United States.
Expert medical writers are key to ensure that regulatory documents such as clinical evaluation reports (CERs) and technical files, meet these rigorous standards.
Medical devices and IVD products are becoming increasingly sophisticated, incorporating advanced technologies such as AI, machine learning, and personalized medicine. This complexity requires precise and clear documentation to accurately describe the device’s function, usage, and benefits.
There is a growing demand for robust clinical evidence to support the safety and efficacy of medical devices and IVDs. Expert medical writers can play an indispensable role in documenting, reporting, and interpreting clinical studies, as well as in compiling systematic literature reviews that serve as input or feedback to the risk management and design control process of devices.
Regulatory bodies are increasingly focusing on the post-market surveillance of medical devices and IVDs to monitor their performance and safety once they are on the market. This requires ongoing documentation, adverse event reporting, and updates to technical files, which can be efficiently managed by skilled medical writers.
As companies expand into new markets, they must comply with the regulatory requirements of each region. Expert medical writers play a crucial role in adapting and translating documentation to meet the specific needs and regulations of different countries.
There is an increasing emphasis on demonstrating the economic value and impact of medical devices and IVDs on patient outcomes. Expert medical writers are needed to develop HEOR reports, cost-effectiveness analyses, and value dossiers.
The integration of new technologies into medical devices and IVDs necessitates detailed documentation to explain the technology, its application, and its impact o diagnostics and treatment.
The rapid pace of innovation in the medical device and IVD fields means that new products and updates are constantly being developed. Expert medical writers help streamline the documentation process, allowing for quicker and more efficient product launches.
Compliance with international standards such as ISO 13485 requires comprehensive documentation on quality management processes, which expert medical writers are well-equipped to handle.
Clear and effective communication with various stakeholders, including healthcare professionals, patients, regulatory authorities, and investors, is crucial. Expert medical writers ensure that complex scientific and technical information is conveyed accurately and concisely, with a compelling narrative and excellent readability.
We deliver medical writing that’s precise, concise, and pragmatic. Specializing in medical devices and IVDs, we focus on what matters:
clear, to the point documentation that meets regulatory standards without unnecessary complexity.
We deliver tailored, end-to-end solutions for your specific needs. Whether you require assistance with a single task or a comprehensive project, we provide expert services with clear timelines and deliverables.
Need dedicated expertise for ongoing or long-term support? We offer flexible staffing options to integrate seamlessly with your team and processes.
MD, PhD and medical writer with 15+years of experience. Extensive expertise in clinical evaluation of medical devices and writing scientific publications.
Special interest in evidence synthesis and focused on taking a clinical and patient-centric perspective. Experience in data management for clinical trials. Long-term EMWA member.
Bio-engineer with 20+ years of experience in clinical research, regulatory and quality for medical devices and IVDs.
Special interest in business and company development and focused on pragmatism and result-driven solutions for clients. Co-founder of the Medtech CRO TRIUM.
Our unique combination of decades of expertise in both medical writing and clinical operations, exclusively for medical devices and IVDs, enables us to truly fulfil your medical writing needs – to the point.
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