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.

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 QbD Group, 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.

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

Regulatory compliance

QbD IVD|Qarad 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 QbD Group 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 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.

We have a class A IVD, do we still require all clinical evidence documentation?

Regardless of the class of the IVD, complete technical documentation is required for the device. While Class A devices may not have their technical documentation reviewed by a Notified Body, a performance evaluation still needs to be documented. Depending on the nature of the Class A device, different performance characteristics may apply and need to be evaluated. QbD IVD | Qarad can assist you in defining how to approach the performance evaluation of your Class A device.

Do I need to monitor the safety and performance of my legacy device on the market in the EU?

Yes, during the transitional period, manufacturers of legacy devices need to set up a PMS system compliant to the IVDR requirements. Some aspects might not be applicable, such as the SSP. While a PSUR is not required, a PMS report is applicable to all legacy devices. Furthermore, the PMPF requirements also apply to legacy devices. The IVDR PMS requirements apply from May 26, 2022.

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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.

Resources

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Discover all

Medical Writing for In Vitro Diagnostics

What is medical writing?

Why is medical writing important?

How can we help?

Regulatory compliance

Literature search skills

Domain knowledge

Collaboration

Our medical writing services

Why QbD Group?

We have a class A IVD, do we still require all clinical evidence documentation?

Do I need to monitor the safety and performance of my legacy device on the market in the EU?

Get in touch

Resources

Fast-Tracked Site Qualification for Clinical Trial Submission

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

CE Mark Renewal for bioXtra Products: A Success Story

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter