DOC
Firstname Lastname Technical Writer & Information Strategist
Available for Contract & Consulting Projects

Transforming Complex Technical Systems into Clear, Compliant Documentation.

Specializing in Standard Operating Procedures (SOPs), regulated MedTech protocols, API developer quickstarts, and structured information architecture. Designed for clarity, accuracy, and audit-readiness.

ISO 13485 Compliant FDA 21 CFR Part 11 REST API & OpenAPI Markdown & Docs-as-Code
Documentation Metrics ● Live Preview
100%
ISO 13485 Structure Alignment
-45%
Average Onboarding Time Reduction
Core Expertise & Deliverables
  • Standard Operating Procedures (SOPs) & Runbooks
  • User Guides & Interactive Quickstarts
  • API Reference & Developer Guides
  • Information Architecture & Knowledge Audits

Work Samples & Case Studies

Interactive Documentation Showcase

Select a category below to inspect full, formatted documentation samples with real-world regulatory and technical standards.

ISO 13485 / MedTech SOP-2026-04

SOP: Calibration & Preventative Maintenance Protocol

Standard Operating Procedure for Class II medical device servicing, structured under FDA 21 CFR Part 11 and ISO 13485 audit controls.

Risk Mitigation Audit Trail Safety Precautions
Read Time: 4 mins
Developer API REST / OAuth2

API Integration Quickstart & Authentication Guide

Developer-facing quickstart guide for token authentication, webhook setup, and error handling with cURL and Python code snippets.

cURL / JSON OAuth 2.0 Error Codes
Read Time: 3 mins
Before & After Case Study UX Rewrite

Documentation Audit & Redoc: System Restore Workflow

A complete restructuring of a confusing legacy troubleshooting manual into an actionable, task-based user document.

Content Audit Task-Based UX Active Voice
Read Time: 5 mins

Methodology & Rigor

Structured Authoring Process

How every document is researched, authored, and verified for compliance and end-user clarity.

01

SME Interviews

Gathering raw requirements directly from engineers, quality assurance managers, and product leads.

02

Audience Mapping

Structuring terminology and task hierarchies specifically for lab technicians, developers, or end-users.

03

Standardization

Applying strict style guides (Microsoft Manual of Style, ISO guidelines) and safety warning hierarchies.

04

Audit Validation

Verification testing and formal QMS approval cycles before release into active production.

About Me

Technical Precision Meets Human Readability.

I am a Technical Writer dedicated to bridging the gap between engineering specifications and end-user clarity. Whether building ISO 13485 compliant Standard Operating Procedures or designing REST API quickstarts, my priority is delivering documentation that reduces support load and passes regulatory audits.

✓

Regulated Documentation: ISO 13485, FDA 21 CFR Part 11, Quality Management System (QMS) integration.

✓

Docs-as-Code & Authoring: Markdown, Git workflows, Astro, VS Code, OpenAPI/Swagger.

✓

Content Redesign: Auditing legacy PDF manuals and converting them into scannable web documentation.

Core Toolkit & Standards

Technical & SOP Writing 95%
Regulatory Compliance (ISO / FDA) 90%
Markdown & Static Site Generators 88%
Looking for a full CV / Resume? Download PDF

Let's Connect

Ready to Elevate Your Documentation Quality?

I am available for contract projects, documentation audits, and technical writing engagements. Reach out directly to discuss your project requirements.

contact@firstnamelastname.com
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