Medical Writing for Medical Devices

In this highly regulated life sciences industry, high-quality medical writing is not just important— it's crucial for regulatory compliance, patient safety, and the successful launch of your products.

Our team offers complete medical writing services that bridge the gap between scientific data and essential communication. Whether you’re in medtech, biotech, or pharmaceuticals, we support your regulatory and clinical documentation needs, and can even provide tailored coaching and training for your team.

What is medical writing?

Medical writing plays a crucial role in creating high-quality regulatory and clinical documents for life sciences industry. With global regulations like the FDA’s Code of Federal Regulations, the EU’s MDR, 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: properly documents product safety and efficacy, avoids delays, and prevents non-compliance.
Clinical trials: guides trial execution, supports ethical conduct, and enhances trial success.
Business impact: influences market access, and patient benefit.
Science communication: communicates complex scientific data clearly and effectively to diverse audiences.
Evidence-based decision-making: provides evidence to support product claims, influence regulatory decisions, and guide post-market surveillance.

Discover how we can support you

Regulatory compliance

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

Literature search skills

Well-planned 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.

Clinical documentation

Investigator Brochures, Protocols, and Clinical Study Reports are vital for clinical studies. Our experts ensure accuracy, consistency, data security, and clarity, delivering documents with purpose and precision. We also produce lay language summary reports as needed.

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.

Scientific communication

We communicate scientific information about medical products to diverse audiences, including peer-reviewed journal papers, educational and marketing documents, and patient materials.

Why QbD Group?

Our medical writing team has the expertise to guide you through every regulatory step with ease. We understand the challenges of medical device development and submission, and we’re here to help you save time and money.

Our team has a strong track record of helping manufacturers achieve CE marking and notified body approval on the first submission, without comments on technical documentation. By choosing to collaborate with us, you will be able to:

Streamline your processes using QbD’s proven methods.
Equip your team with essential regulatory knowledge through training.
Get expert support to create compliant, high-quality documentation.

My device is a low-risk class medical device, do I require a clinical evaluation?

Yes, every medical device that will go to the market under MDR, requires a clinical evaluation, starting with a state-of-the-art literature review and summarizing all data to provide clinical evidence on safety and performance of the medical device. See this blogpost to learn more.

What type of documents are essential for clinical trials?

Depending on the product under evaluation, the MDR or the ICH-GCP guidelines outline the required documents for clinical trials, specifying the necessary content of these documents. In general, this includes:

Clinical Study Protocols: A plan outlining study objectives, design, methodology, and endpoints.
Informed Consent Forms: A document requesting participants' signatures for voluntary participation.
Patient Information Leaflets: Clear and concise information provided to the patient about the study, usually given alongside the Informed Consent Form.
Clinical Study Reports: A comprehensive summary of trial results, required to make the data publicly available.
Investigator Brochure: A summary of the investigational product, including all available pre-clinical and potentially clinical data for the trial investigators.

Get in touch

Do you require medical writing services? We can help you at every step of the product development process, as well as post-market solutions for the lifetime follow-up of safety and performance.

Be sure to contact us!

Resources

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 Medical Devices

What is medical writing?

Why is medical writing important?

How can we help?

Regulatory compliance

Regulatory compliance

Literature search skills

Literature search skills

Domain knowledge

Domain knowledge

Clinical documentation

Clinical documentation

Collaboration

Collaboration

Scientific communication

Scientific communication

Why QbD Group?

My device is a low-risk class medical device, do I require a clinical evaluation?

What type of documents are essential for clinical trials?

Get in touch

Resources

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