Technical writing is perhaps recognized as a style of writing used for everything from office documents, company policies, quality procedures to technical manuals and user guides. For decades, technical writing has been a part of science and engineering. However, it has emerged as a distinctive tool during the transition towards Information Age as computer professions began taking center 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 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 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
Medical devices and health care are important fields for technical writing. Modern medicine and medical devices are extremely techy and demand high-quality IFUs & manuals as human lives & their well-being depend upon them.
Medical devices can be complex and require users to understand specific information about storage, intended use, disposal or reprocessing, and operations. Although to the greatest extent possible, it is favorable 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 the operation manual, Instructions for Use (IFU), user guide, installation manual, and service manual.
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 things as:
- Product name
- Document or model number
- Table of content
- 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
- Warranty information
Typically, an IFU includes basic operational information as well as pages of 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 the respective country Health Authority requirements.
Importance of Professional Technical Writing Services
The term ‘professional technical writer’ only seems easy and straightforward. However, it takes a lot of skills and knowledge to be a technical writer, as for being a professional one – experience is the best compliment of these skills. Our team of technical writers comes with extensive experience in the pharmaceutical, health care, and medical device manufacturing industries. Following are some key skills of a technical writer –
- 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
These skills are just a small part of what a technical writer can offer.
Having prior industry knowledge and as a leading player in medical device Regulatory services, Freyr understands the importance of producing quality technical documents for Medical Devices. Our technical writers create documents aligning with Regulatory requirements and specific to client products. Freyr offers professional technical writing services for:
- Operation Manuals
- Service Manuals
- Instruction for Use (IFU)
- Installation Guides
- Standard Operating Procedures (SOPs)
- Validation Protocols
- Software User Guides
- Work Instruction Guides
- Quick Reference Guides
At Freyr, our Technical Writers understand the documentation mandates set forth by the regulators such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), Health Authorities, and other governing bodies. All the offerings comply with the labeling requirement and services of the client’s products.
- Experienced team of technical writers
- eDocuments- digital compliant documentation:
- Simple, customer-friendly process
- Reduced risk with Regulatory compliant documentation
- Full compliance with medical device regulations
- Translation ready
- Sample templates for ready reference
Freyr offers a robust combination of technology and Regulatory expertise to ensure product continuity, label compliance, and quality technical documents.