The rapid rise of artificial intelligence (AI) and large language models, such as GPT-4, has transformed how content is created across industries, including medical and regulatory writing. Many MedTech companies now wonder whether AI tools can replace human medical writers for developing Clinical Evaluation Reports (CERs), regulatory submissions, technical documentation, and other documents. While AI offers undeniable efficiencies, there are crucial reasons why expert medical writers remain indispensable. At RQM+, our AI philosophy is driven by finding ways that AI can empower humans to be more efficient, but not to replace them. This evolution represents a shift toward human-AI collaboration rather than substitution.
What Do Medical Writers Do in MedTech?
Medical writers in MedTech occupy a vital space between science, regulation, and communication. They craft and organize complex technical documents that communicate scientific evidence, safety, and performance in a way that meets regulatory expectations. Their work includes:
- Clinical Trial Protocols and Reports.
- Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) documentation.
- Regulatory submissions such as FDA 510(k)s, De Novos, PMAs, and EU MDR Technical Documentation.
- Risk-benefit analyses, scientific publications, and investigator brochures.
Medical writers ensure documents are clear, accurate, and compliant with regulations and guidances such as the EU MDR, MDCG guidance, or FDA guidance. They collaborate with cross-functional teams—engineers, clinicians, statisticians, and regulatory specialists—to interpret complex data and craft a logical, evidence-based narrative. Their expertise lies not just in writing, but in scientific interpretation, regulatory alignment, and narrative coherence—areas where automation struggles.
How AI Is Changing the Writing Process
AI-driven writing tools have introduced real efficiencies. Generative AI can summarize literature, draft background sections, or refine grammar and phrasing. These tools help writers focus on higher-value tasks, such as analysis, interpretation, and strategy.
However, AI’s capabilities have limits. Large language models draw from vast datasets, but they lack contextual understanding of a specific medical device or regulatory framework. They can produce outdated or inaccurate information, or even fabricate plausible but false content (“hallucinations”). In medical and regulatory writing, where precision, traceability, and compliance are core, such errors are unacceptable. AI also cannot evaluate confidential manufacturer data or weigh subtle regulatory nuances, both of which are critical for compliant submissions.
Regulatory Requirements and the Need for Human Accountability
Regulatory authorities and scientific publishers consistently emphasize human accountability. The International Committee of Medical Journal Editors (ICMJE) and major medical journals explicitly state that AI tools cannot take authorship, a human must accept responsibility for the content’s integrity. In regulatory contexts, qualified professionals must sign reports such as CERs or PMCF evaluations, attesting to their accuracy.
Confidentiality and data protection also remain central concerns. Public AI models pose risks when used with proprietary or sensitive data. Medical writers manage this by ensuring secure data handling and full compliance with data privacy standards. They verify every citation, cross-check every claim, and tailor the message to regulatory expectations, a process requiring discernment that no AI can yet replicate.
AI as an Augmentation Tool, Not a Replacement
The most effective strategy is not replacing medical writers, but augmenting them. AI can handle structured, repetitive, or linguistic tasks, such as creating initial drafts when authors face writers’ block, summarizing standard sections, or flagging inconsistencies, while human writers provide the oversight, validation, and strategic interpretation.
Using AI-assisted workflows writers can exemplify this model: automating low-level authoring tasks to improve consistency and free writers for higher-order analysis. Human writers contribute the critical thinking that ensures:
- Regulatory criteria are fully addressed.
- Evidence is interpreted correctly and ethically.
- The overall document narrative remains coherent and persuasive.
AI can generate content, but it cannot judge whether an argument aligns with EU MDR or FDA standards. Only an experienced writer can.
Pitfalls of Relying Solely on AI
Several risks accompany an AI-only approach:
- Accuracy and truthfulness: AI systems may invent citations, misinterpret data, or fabricate statistics. One false statement could invalidate a regulatory submission or compromise patient safety.
- Nuance and tone: Regulatory documents require precise language. The difference between “may improve” and “is proven to improve” can determine compliance. AI lacks this contextual awareness.
- Up-to-date knowledge: Regulations evolve rapidly. While human writers track the latest EU MDR and FDA guidances and best practices, AI models operate on static training data.
- Ethical and legal accountability: AI cannot sign off on legal attestations, disclose its own use, or assume responsibility for errors. Human oversight is indispensable for ensuring ethical compliance.
As the American Medical Writers Association (AMWA) notes, “chatbot output currently carries the risk of including biases, distortions, irrelevancies, misrepresentations, and plagiarism”. The World Association of Medical Writers has subsequently issued new recommendations, including: “chatbots cannot be authors”. Removing humans from the process thus risks both compliance failures and reputational harm.
The Value of Human Expertise and Insight
Human medical writers bring more than writing skill,they bring judgment, and strategic foresight. Many have clinical or scientific backgrounds, enabling them to:
- Interpret complex data and extract clinically meaningful insights.
- Craft cohesive narratives that preempt regulator concerns.
- Collaborate across departments to gather inputs and resolve inconsistencies.
- Ensure that every claim, table, and conclusion aligns with regulatory expectations.
Complex documentation is inherently iterative and collaborative. It involves human negotiation, prioritization, and decision-making, dimensions that AI cannot reproduce.
An apt analogy: AI is like an autopilot. It can handle certain aspects of flight efficiently, but a human pilot must manage takeoff, landing, and any turbulence. Likewise, AI can draft or format content, but human medical writers must steer the document to regulatory approval.
Closing Thoughts
AI is transforming medical and regulatory writing, but not by replacing humans. Companies like RQM+ demonstrate how AI-driven processes can enhance efficiency without sacrificing quality. The human writer’s role is evolving, from content producer to strategic editor, quality gatekeeper, and regulatory storyteller.
Ultimately, regulators, investors, and patients place their trust in human accountability. AI can augment intelligence, but it cannot substitute it. The future of medical writing is human-guided automation, where skilled writers harness AI to deliver faster, more accurate, and more consistent documentation, while ensuring that every word stands up to scientific and regulatory scrutiny.
References
- Brave New World: Authorship and AI in Medical Writing. American Medical Writers Association. 2023. https://blog.amwa.org/brave-new-world-authorship-and-ai-in-medical-writing.
