Medical Writing Services for Medical Devices and IVDs
From regulatory documentation to publications and communication materials
High-quality documentation is essential throughout the entire clinical development lifecycle — from early planning to CE marking and post-market stages.
Our medical writing team supports you with scientifically sound, compliant, and clearly structured documentation for both medical devices and in vitro diagnostics (IVDs).
We combine regulatory insight, clinical understanding, and communication expertise to ensure your documents not only meet MDR and IVDR requirements — but also tell your story clearly and credibly.
Our writing services
We prepare and review all types of documentation related to your clinical and regulatory strategy:
Clinical Evaluation and Performance Evaluation Documentation
- Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER)
- Clinical Evaluation Plans (CEP) and Performance Evaluation Plans (PEP)
- State-of-the-Art (SotA) literature reviews
Clinical Investigation and Clinical Performance Study Documentation
- Clinical Investigation Plans (CIP) and Clinical Performance Study Plans (CPSP)
- Investigator’s Brochures (IB)
- Clinical Investigation/Performance Study Reports (CIR/CPSR)
- Informed Consent Forms and subject materials
Beyond compliance
- Scientific publications and conference abstracts
- Marketing and educational materials
- Post-market clinical and performance summaries (PMS/PMCF/PMPF reports)
Why professional medical writing matters
Accurate and consistent documentation is critical for demonstrating safety, performance, and clinical benefit — and for ensuring alignment between design, risk management, and post-market activities.
Our writers help you:
- Streamline your documentation across MDR and IVDR requirements
- Translate complex science into clear, reviewer-friendly language
- Maintain consistency across all technical and clinical documents
- Strengthen your evidence base with sound clinical reasoning and traceability
Why Choose Us?
- Specialists in medical devices and IVDs under MDR/IVDR
- Proven experience in ISO 14155 and ISO 20916 study documentation
- Writers with backgrounds in clinical research, life science, and regulatory affairs
- Collaborative approach with your clinical, regulatory, and marketing teams
Bring clarity to your clinical documentation
Whether you need a complete clinical evaluation, a study protocol, or scientific content for publication — we help you communicate your evidence effectively.
Contact us to learn how our medical writing experts can support your next project!