Medical Writing
We help create clear, accurate, and compliant clinical evaluation documentation and design and execute your clinical trials and PMCF Surveys.
We provide a seamless and efficient process
As a MedTech company, you know clinical documentation needs to cover scientifically sound, structured and compliant documents, including a sound clinical strategy and clinical evaluations, gathering Post market clinical follow-up dat or pre-market clinical data supporting the performance and safety of your device for regulatory submissions.
Gathering your own clinical data can be a challenging and complex process. From study design and protocol development to site selection, patient recruitment, study monitoring and data management, it all needs to meet international standards and regulatory guidelines.
At Qserve CRO, we provide unparalleled support for medical device and IVD clinical data collection, with a practical approach and a focus on quality and compliance.
We provide a seamless and efficient process from study design and protocol development to site selection, patient recruitment, and data management. Our experienced clinical research professionals ensure trials are conducted in accordance with international standards and regulatory guidelines. We prioritize patient safety, data integrity, and timely delivery, enabling our clients to advance their products through the clinical development phase.
Satisfied Clients
Our Medical Writing services cover multiple disciplines. Discover them all:
Clinical Evaluation Planning & Reporting (CEP/CER)
We support you in developing robust Clinical Evaluation Plans, literature appraisal and Clinical evaluation Reports.
Periodic Safety Update Report (PSUR)
Our team helps you compile and analyze post-market surveillance data to produce compliant PSURs, highlighting trends, risks, and benefit-risk assessments to maintain regulatory approval and ensure patient safety.
Summary of Safety and Clinical Performance (SSCP)
We create clear, regulator-ready SSCPs tailored for both professionals and patients. These summarize your device’s safety profile, clinical benefits, and performance in accordance with MDR expectations.
Medical writing plays a pivotal role in the success of clinical trials and regulatory submissions.
Non-compliant documents result in delays in the submission process and approvals market clearance. Teaming up with a medtech consultancy firm is a smart move to minimize these risks.
At Qserve, we prioritize accuracy, clarity, and adherence to regulations to ensure your documents meet their objectives.
Our medical writing and CRO team is dedicated to medical device and IVD clinical data collection. We support you during all phases of clinical development, including executing your PMCF surveys and clinical trail management. Our experienced team combines high quality with a practical approach.
is structured to ensure your clinical documents are accurate, compliant, and ready for submission. We work closely with your team at every stage, from initial planning to final submission, to ensure all documents meet regulatory and scientific standards.
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Why choose Qserve for Medical Writing?
At Qserve, we bring unmatched expertise and dedication to medical writing, ensuring your clinical documents are of the highest quality. Here’s what sets us apart:
Industry Expertise: Our writers are seasoned professionals with extensive experience in clinical trials, regulatory affairs, and medical device development.
Regulatory Focus: We specialize in navigating the complex regulatory landscapes of international markets, ensuring compliance with standards such as MDR, FDA, and ISO 14155.
Tailored Solutions: Every document, from trial protocols to publication strategies, is customized to meet your needs.
Comprehensive Support: We guide you through the entire writing process, from planning to final submission, ensuring your documents are accurate, transparent, and compliant.
What are critical types of medical documents?
Medical writing encompasses a variety of documents tailored to different stages of clinical trials and regulatory submissions. At Qserve, we specialize in the following:
Clinical Evaluation Reports (CERs): These reports demonstrate your device’s safety and performance in compliance with EU MDR requirements.
Study Protocols: Define your clinical investigation’s objectives, methodology, and statistical considerations.
Investigator’s Brochures (IBs): Summarize preclinical and clinical data to inform trial investigators.
Trial Reports: Provide detailed analyses of clinical trial outcomes, including safety and efficacy data.
Recruitment Materials: Develop flyers, brochures, or online content to attract trial participants.
Scientific Publications: Create manuscripts and abstracts for publication in peer-reviewed journals.
Training Slide Decks: Provide educational materials to train investigators and site staff.
Promotional and Educational Materials: Communicate your medical device’s benefits and safety to healthcare professionals and patients. We carefully craft each document to meet your clinical trial’s specific regulatory requirements and objectives.
How does Qserve go about medical writing for medical devices?
Medical devices present unique challenges due to their highly regulated environment and technical nature. At Qserve, we tailor our medical writing services specifically for the medical device industry, ensuring that all documentation meets the required standards while effectively showcasing your device’s safety and efficacy.
Our services for medical device trials include:
Clinical Investigation Plans (CIPs): Develop comprehensive trial designs aligned with regulatory requirements.
Study Reports: Present detailed clinical trial data for submission to regulators.
Scientific Publications: Share findings with the scientific community to build credibility and support your device.
Technical Documentation: Prepare regulatory documents in compliance with ISO 14155, MDR, and FDA guidelines.
Our team’s experience ensures that your clinical documents meet compliance requirements and effectively communicate your device’s value and safety to regulators and stakeholders.
What is the medical writing process of Qserve?
Strategic Planning
We begin by defining each document’s objectives and scope and collaborating with your clinical and regulatory teams to identify key outcomes, timelines, and compliance requirements. The strategic planning ensures that every document aligns with your goals and regulatory expectations.
Content Development
Our expert medical writers synthesize clinical data in a clear, structured format at this stage. We tailor the content to meet regulatory guidelines such as ISO 14155 and ICH-GCP while ensuring scientific accuracy and clarity.
Quality Review and Publication
Before final submission, we perform rigorous quality checks to ensure the document is error-free, adheres to formatting guidelines, and meets the standards of regulatory authorities or scientific journals. Our team ensures that your documents are polished and submission-ready.