Medical Device Technical Writing Services

Freyr's medical device technical writing services encompass a wide range of offerings to enhance your product documentation and overall customer experience. From content management and migration to standardization and tool strategy implementation, we ensure that your technical documentation meets the global Unique Device Identification (UDI) compliance standards.

For Regulatory Success, Contact Now!

Send us your details and we will get in touch.

Medical Device Technical Writing Services – Overview

Technical writing is recognized as a style of writing used for everything, from office documents, company policies, and quality procedures to technical manuals and user guides. For decades, technical writing has been a part of science and engineering. However, medical device technical writing services have emerged as a distinctive tool during the transition toward the age of information and technology as computer-based professions began taking centre stage.

For a long time, many companies believed that anyone with good communication skills could write a technical document. Often the task of gathering technical information, writing, editing, and reviewing was given to someone without professional writer’s training or even basic writing skills. The fast-developing companies in recent times have understood the importance of producing clean, coherent, and crisply written documents that are easy to comprehend.

Technical writing services and the need for technical writers gained momentum with the importance of having clear, concise, and target audience-driven documents that comply with quality and regulation requirements. Major contributing factors have been the healthcare, pharmaceutical, and medical device manufacturing industries that traverse the globe and involve international standards.

Technical Writing for Medical Devices

Modern medicines and medical devices are extremely techy and demand high-quality Instructions for Use (IFUs) and manuals as human lives and their well-being depend upon them. Thus, the medical device and healthcare industries require experienced technical writers.

Medical devices can be complex and require users to understand specific information on storage, intended use, disposal or reprocessing, and operations. Although to the greatest extent possible, it is favourable to guide the use of devices via intuitive design, manufacturers are increasingly relying on instructional materials to convey important information supporting safe and effective product use.

Essentially, all medical devices require documents, including but not limited to operation manuals, IFUs, user guides, installation manuals, and service manuals.

Operation manuals are required for various medical devices, medical instruments, and Software as a Medical Device (SaMD). Depending on the product type, an operation manual might include:

  • Product Name
  • Document or Model Number
  • Table of Content
  • Index
  • Contact Details
  • Intended Use
  • Intended Users
  • Technical Specifications
  • Description of the Main Product Elements
  • Description of the User Interface
  • Safety Warnings
  • Description of How to Use/Operate the Product
  • Basic Troubleshooting Methods
  • Information on Safe Disposal of the Product and Packaging
  • Glossary
  • Warranty Information
  • Licenses

Typically, an IFU includes basic operational information as well as pages containing warnings, cautions, and other generic or device-specific information beyond the basic “how to” procedures. Operational troubleshooting, contingency instructions, and maintenance information can also be included. All of this is consistent with respective countries’ Health Authority (HA) requirements.

Importance of Professional Technical Writing Services

The term “professional technical writer” seems easy and straightforward. However, it takes extensive skills and knowledge to become a technical writer, and as for being a professional one, it requires experience. Our team of technical writers comes with extensive experience in the pharmaceutical, healthcare, and medical device manufacturing industries. Some key skills of a professional technical writer are as follows:

  • Writing and Technical Skills
  • Good Communication Skills
  • Design Skills
  • Ability to Work with Technical Writing Tools
  • Research and Exploration Skills
  • Proofreading Skills
  • Critical Thinking and Sociology
  • Analytical and Logical Understanding

However, it must be noted that these skills are just a small part of what a technical writer has to offer.

Technical writers at Freyr understand the documentation mandates set forth by the regulators such as the United States Food and Drug Administration (US FDA), the International Organization for Standardization (ISO), HAs, and other governing bodies. All our offerings and services comply with the labeling requirements of the customer’s products.

Medical Device Technical Writing Services

  • Operation Manuals
  • Service Manuals
  • IFUs
  • Installation Guides
  • Standard Operating Procedures (SOPs)
  • Validation Protocols
  • Software User Guides
  • Work Instruction Guides
  • Quick Reference Guides
  • An experienced team of technical writers.
  • Cost-efficient.
  • eDocuments – digital-compliant documentation.
  • Simple, customer-friendly process.
  • Reduced risk with Regulatory-compliant documentation.
  • Full compliance with medical device regulations.
  • Translation services.
  • Sample templates for ready reference.