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Medical Writing and Consulting
for Medical Device Regulatory Compliance

with Excellence, Quality, and Care

Our Services

Tailored Consulting Solutions

EU MDR:

  • Gap analyses

  • Mock audits

  • Review of Templates and SOPs to optimize workflows, reduce duplication of content or effort, and improve team efficiencies.

  • Template formatting: fix and optimize formatting in templates.

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Portfolio and Project Management:

  • Portfolio-wide EU MDR Document Lifecycle Tracking Tools: know when each document needs to be updated, track progress and project duration, monitor portfolio-wide metrics dashboards, calculate resourcing needs. Tools are customized to follow your QMS. 

  • Project timeline templates, tools for coordinating and tracking cross-functional inputs and reviews

  • Framework for streamlining document updates ​​

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Training:

  • We train and mentor your junior staff on EU MDR, Clinical Evaluations, and general medical writing proficiency. We offer training sessions and/or hands-on training through the execution of their project. 

Clinical and Regulatory Writing

EU MDR Documents:

  • Clinical Evaluation (CEP, CER, SSCP)

  • Post-Market Surveillance (PMS-P, PMS-R, PSUR)

  • Post-Market Clinical Follow-up (PMCF-P, PMCF-R, surveys, registries)

  • Risk (RMR, RBA)

  • SOPs and Templates

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Literature Reviews: 

  • Systematic Literature Reviews

  • Meta-analyses

  • Literature Search Protocols, with search query development

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Other

  • Clinical Studies (Protocols, CSRs)

  • UK PSURs

  • Health Canada Summary Reports

  • TGA CERs

  • Publication Writing (Systematic Reviews, Meta-analyses, Research Papers, Case Reports, Conference Abstracts)

  • Data Analysis (complaints, MAUDE, etc.)

Our Approach

At Writeline Consulting, we are a small but mighty team of seasoned managers and medical writers with a collective experience of hundreds of regulatory submission projects across all types of medical devices. We have worked side by side for years, supporting clients with regulatory documentation, clinical evaluations, and consulting that meets the highest standards of regulatory compliance and clarity.

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What sets us apart is not just our expertise, it’s how we engage with you.

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We do not follow a one-size-fits-all approach. Instead, we begin by asking: How do you want us to work with you? Flexible timelines, tailored scopes of service, or creative resourcing strategies, we will adapt to your needs. We are open to negotiating ways of working, rates, and deliverables because true partnership means listening first.

Deliver Outstanding Work

Help Meet Your Goals

Build Genuine Relationships

Enjoy The Process Together

About Writeline

At Writeline Consulting, we believe the best work comes from people who are respected, supported, and inspired. Our product is our people, and we invest in them fully. By fostering an environment of trust, collaboration, and balance, we empower exceptional professionals to deliver work of the highest quality while making space for life beyond the office.

We hold all employees to a high bar of technical competence and creativity, but we balance those expectations with care: proper resources, recognition, and a culture of collective success. When our teams thrive, so do our clients.

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We understand our clients' challenges and we have been in their shoes: navigating tight budgets, ambitious OKRs, and managing team workload, morale, and retention. This is why we commit to being a true partner: listening, adapting to constraints, and delivering polished work that makes your job easier, not harder.

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Writeline Consulting is built on respect; for employees, for clients, and for the work itself. We don’t just deliver solutions; we build long-term partnerships grounded in trust, flexibility, and shared success.

Let's Collaborate

Contact Us

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