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 Labmark 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.

What is medical writing?

Medical writing plays a crucial role in creating high-quality regulatory and clinical documents in the IVD industry. With global regulations like the FDA’s Code of Federal Regulations, the EU’s IVDR, ICH-GCP guidelines, and ISO standards, manufacturers must meet a complex set of requirements.

These regulations ensure companies maintain robust quality management systems and generate precise, well-documented clinical evidence, ultimately protecting patient safety, proving product efficacy, and helping products successfully reach the market.

At Labmark, our expertise and years of experience enable us to create documentation that meets the strictest regulatory standards, ensuring your products get to market smoothly and efficiently.

Medical Writing for In Vitro Diagnostics - Clinical - QbD Group

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.

Discover how we can support you

How can we help?

Regulatory compliance

Labmark provides high-quality regulatory documents, adhering to guidelines and regulations, while ensuring data integrity.

Literature search skills

Systematic literature searches using appropriate keywords and diverse sources are critical for evidence-based writing.

Domain knowledge

Our medical writers leverage their expertise in therapeutic areas, regulatory guidelines, and statistical concepts to simplify complex medical information into clear, concise content.

Collaboration

We foster cross-functional teamwork, aligning Labmark departments and clients for effective problem-solving and decision-making. Our coaching and training services ensure solutions tailored to client needs.

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 Labmark?

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.