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Regulatory compliance
QbD IVD|Qarad provides high-quality regulatory documents, adhering to guidelines and regulations, while ensuring data integrity.
Medical Writing for In Vitro Diagnostics
When it comes to in vitro diagnostic medical devices (IVDs), having clear, precise, and compliant clinical evidence documentation is critical.
Whether you're preparing pre-market submissions or managing post-market requirements, the quality of your documentation directly impacts your product's success. That's where we come in.
Our QbD IVD|Qarad team with years of experience, offers writing, consulting, and documentation services for IVD and CDx companies.
Need IVDR-compliant clinical evidence documentation? Let’s connect.
Why is medical writing important?
- Regulatory compliance: ensures product safety and efficacy, avoids delays, and prevents non-compliance.
- Clinical performance studies: guides study execution, supports regulatory submissions, and enhances regulatory approval.
- Business impact: influences market access, revenue, and patient benefit.
- Risk mitigation: minimizes risks, reduces adverse events, and prevents product recalls.
- Science communication: communicates complex scientific data clearly and effectively to diverse audiences.
- Evidence-based decision-making: provides evidence to support product claims, influences regulatory decisions, and guides post-market surveillance.
How can we help?
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Our medical writing services
We can help you with writing:
- IVDR specific clinical evidence documentation
- Performance evaluation plans and reports
- Analytical and clinical performance reports
- Scientific validity reports and state-of-the-art reports
- Documents related to clinical performance studies, including investigator brochures, clinical performance study plans and reports, informed consent forms.
- Post-market documents including post market surveillance and performance follow-up plans and reports.
- Summary of safety and performance
Our medical writers focus on getting the details right, ensuring consistency, and protecting your data. With a mix of critical thinking and creativity, we craft documents with a clear objective.
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Why QbD Group?
Our experience in successfully helping IVD manufacturers through Notified Body reviews and CE marking means we truly understand the complexities and challenges involved.
Here's why we’re your trusted partner:
- Proven success: our pragmatic approach and tailored services are recognized by Notified Bodies for consistently delivering results.
- Expert guidance: from clinical/regulatory advice to training and documentation review, we help you build a “first-time-right” clinical evidence strategy.
- Hands-on support: our medical writing team can handle everything, from specific documents to full technical submissions.
- Quality you can rely on: our systematic processes ensure top-quality, consistent documentation that meets Notified Body standards.
- Gap identification: our pre-submission reviews identify documentation gaps, streamlining your Notified Body review process.
- Time and cost savings: partnering with our experienced medical writers saves you both time and money, allowing you to focus on what matters most.
Get in touch
Whether you have a straightforward need or an interest in our services without a clear scope yet, our business development experts will work with you to define the scope and a tailored approach to meet your company’s needs.
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