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 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 Medical Devices - Clinical

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

How can we help?

Regulatory compliance

Labmark 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 Labmark 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 Labmark?

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