Overview:
In
the world of medical device manufacturing, technical writing is more than just
a skill—it’s a necessity. Every document, from user manuals and regulatory
submissions to product specifications and standard operating procedures (SOPs),
plays a crucial role in ensuring safety, compliance, and usability. A
well-written document can guide a healthcare professional in using a device
correctly, help a manufacturer secure regulatory approval, and ensure that a
product meets both industry and end-user expectations. But when documentation
is unclear, the consequences can be significant—delays in regulatory approval,
product recalls, increased liability, and even risks to patient safety.
Consider
a user manual for a new infusion pump. If the dosage settings are described in
technical jargon with no clear explanation, a nurse or doctor may misinterpret
the instructions, leading to incorrect medication delivery. Now imagine the
same manual written with clarity, logical structure, and accessible language—it
not only ensures compliance but also prevents errors that could compromise
patient health. The difference between effective and ineffective technical
writing in this industry isn’t just about readability—it’s about real-world
impact.
For
technical writers working in medical device manufacturing, the challenge is
twofold: they must accurately translate complex technical details while
ensuring their content is clear and accessible to a diverse audience, which may
include engineers, regulators, healthcare professionals, and even patients. As
medical technology advances and global regulations tighten, writers in this
field must adapt to new requirements, evolving industry expectations, and the
increasing complexity of medical devices.
This
webinar is designed to help technical writers refine
their skills and navigate the intricate landscape of medical device
documentation. Whether you’re drafting risk assessments, labeling requirements,
or post-market surveillance reports, the ability to communicate technical
information with precision, clarity, and compliance is essential.
- But how do you structure information so that it’s both comprehensive and easy to follow?
- How do you ensure regulatory compliance while keeping documents readable?
- What
happens when a document fails to meet industry standards?
These
are the kinds of questions every technical writer must ask.
In this session, attendees will gain insights into best practices, writing techniques, and industry trends to help them create documents that not only meet regulatory standards but also enhance usability. By learning how to adapt writing styles for different audiences, streamline editing and proofreading processes, and structure content effectively, participants will be equipped to produce documentation that is both technically accurate and user-friendly.
Areas
covered in the session:
- Overview
of technical writing
- Understanding
your audience
- Structuring
your content
- Writing
style and tone
- Editing
and proofreading techniques
- Key
take aways
Why
should you attend?
Technical
writing in medical device manufacturing is more than just putting words on
paper—it’s about ensuring that critical information is clear, accurate, and
compliant. Whether you’re explaining device functionality to end-users or
preparing documentation for regulatory approval, the ability to communicate
complex information effectively is essential.
This webinar will help you refine your writing skills, ensuring that your documents are not only technically sound but also easy to understand for diverse audiences. You’ll gain insights into best practices, industry expectations, and strategies to enhance clarity, structure, and compliance in your writing.
Who
Will Benefit?
This
webinar is ideal for professionals involved in technical documentation,
regulatory compliance, and content development within the medical device
industry. Those include:
- Technical
Writers
- Medical
Writers
- Regulatory
Affairs Specialists
- Quality
Assurance Professionals
- Compliance
Officers
- Documentation
Managers
- Clinical
Research Associates
- Product
Development Professionals
- Manufacturing
Engineers
- R&D
Specialists
- Instructional
Designers
- Process
Improvement Analysts
- Medical
Device Trainers
- Technical
Communicators
- Validation
Specialists
- Risk
Management Professionals
- FDA
Submission Writers
- SOP
Writers
- Labeling Specialists
- Device Approval Coordinators
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Enrollment Options
Tags: technical writing, medical device, compliance, documentation, regulatory affairs, quality assurance, user manuals, SOP, labeling, FDA compliance, writing best practices, medical device industry, regulatory submissions, structured documentation, risk management, Jose Mora, March 2025, Webinar