In today’s highly regulated medical device environment, clear, compliant, and scientifically robust documentation is essential – not only for regulatory approval but also to build trust with notified bodies, competent authorities, and healthcare professionals. Medical Writing has always been a crucial activity for the medical device industry. However, the increased level of scrutiny to clinical requirements and scientific justification added by the publication of the Medical Devices Regulation (MDR) made this activity even more relevant.
Successful medical writers have the ability to bridge science and regulatory affairs in a very structured way that keeps the target audience in mind. In some cases, the audience is a regulatory agency, at other times it could be a healthcare professional or a patient. A deep understanding of how to communicate effectively with each group ensures success of the final product.
Additional competences that make medical writers good at their jobs are:
- Deep regulatory knowledge,
- Scientific background,
- Structured and objective writing,
- Critical thinking,
- Analytical skills,
- Cross-functional team communication,
- Project management skills,
- Attention to detail,
- Ethics and regulatory integrity, and
- Continuous learning.
This is a very specific set of skills that are hard to find and, most likely, require at least some degree of investment. Outsourcing medical writing may be a good choice for medical device manufacturers with limited personal or with time constraints, as it avoids climbing this steep learning curve.
Qserve offers complete medical writing services, performed by well-experienced and continuously trained professionals that can defend regulatory challgenges from an audit. Our medical wirting services can be acquired by modules, which allows manufacturers to take most advantage in activities where there is a bigger internal gap in knowledge and skills, while having better control of the budget. The most common modules are detailed below:
Clinical Strategy
Strategy is an important step to assess whether the available clinical data is able to provide sufficient evidence that all device claims are fully supported, or to define which steps are necessary to get there in a more efficient manner. Either way, Qserve will be focusing on smart resolutions which will require less time and budget from the manufacturer. The ultimate goal of this module is to align available data and/or data collection to ensure that the best regulatory strategy will be used in the clinical evaluation, helping decision-making throughout project development.
Literature Search Design
Systematic literature search design involves defining research questions, identifying keywords, selecting appropriate databases and developing search strings using Boolean operators. It is an iterative process, requiring search execution, result evaluation, refinement of the strategy and documentation for comprehensiveness and reproducibility. A bad search design will potentially waste a lot of time in appraisal of irrelevant data. Therefore, in this module, Qserve will focus on ensuring that the research question is scientifically sound while ensuring regulatory requirements are met. While this activity is regularly performed for clinical evaluation for the EU MDR, the process can also be used to identify clinical data required for some 510K submissions for the FDA. Literature search design can also be applied to benchmarking/innovation research, residual risks and risk acceptability (ISO 14971), biocompatibility (ISO 10933), health impact assessment for reimbursement, and others.
Literature Search Appraisal and Data Extraction
The appraisal of the literature includes selecting the best criteria for data inclusion/exclusion. This step will ensure the quality of the data and that both favorable and unfavorable relevant studies are included. Data extraction is the most time-consuming activity of medical writing, and therefore, the one that manufacturers are most likely to outsource due to timeline constraints. Data specific to the clinical outcome parameters used to determine the benefit-risk ratio are extracted from literature and organized for analysis. This module will provide useful data and allow manufacturers to direct their own resources to other activities.
State of the Art (SOTA)
After clinical data is appraised, the included articles should be used to define the SOTA for the relevant current medical practice and clinical condition, which is a requirement for MDR submissions. Putting all studies together is similar to writing a short thesis, and as such, requires a scientific background and strong medical writing skills. This module will provide a well-designed SOTA text, which will be helpful substantiating risk management, device claims, clinical outcome parameters, acceptance criteria, planning data pre-market/post-market data collection and choosing the best clinical evaluation strategy.
Definition of Clinical Outcome Parameters and Acceptance Criteria
Any clinical claim should be linked to clinical outcome parameters and appropriate acceptance criteria which will set the bar for clinical data support. This module will translate claims into outcome parameters currently measured in clinical practice. Manufacturers will benefit from it not only in the clinical evaluation stage, but also in the pre-market/post-market clinical data collection stages, so that any plan can be executed in the most effective way, saving time and directing budget decisions towards the most useful outcomes.
Clinical Evaluation Plan (CEP)
Planning is often underrated, and it is not unusual that unaware manufacturers elaborate the CEP in parallel with the CER. As the clinical evaluation is a process, this module will provide a plan which is useful right in the early stages of design development, allowing cross-functional communication with risk management, clinical affairs and post-market departments. This will set a start with the right foot, which will help to ensure consistency throughout all the technical documentation.
Clinical Evaluation Report (CER)
Notify Bodies (NB) and other regulators complain that they receive many CERs that state that both safety and performance of the device is supported, without sufficient data analysis. In fact, this is one of the most frequently asked questions after technical documentation submission. This module will ensure that all MDR requirements - the gold standard for clinical evaluation - are addressed, and that pre-market, post-market and literature clinical data are translated into high-quality safety and performance clinical evidence. Ultimately, it will decrease the number of questions received and will help your medical device to reach the market sooner.
Responding to Notified Body Queries
Stricter clinical data requirements often lead to a list of questions from a Notified Body. This module will provide a strategy for response, even if Qserve did not write the technical documentation submitted. Our experienced team can also write the responses and make edits to technical documentation where required. In each case we will keep the manufacturer's budget and timelines for response in mind.
Summary of Safety and Clinical Performance (SSCP)
The SSCP is not just a summary of the CER. Besides having its own requirements, its content is designed to be publicly available in Eudamed. This module will deliver compliant documentation, including appropriate language for the intended user and/or patient, and also advise manufacturers how to disclose any sensitive information.
Training
Qserve offers basic, advanced and customized training for all aspects of medical writing and related regulatory documentation. Those can be performed on demand via the Qserve Learn electronic platform, scheduled broadcasted online or in-company. This module will allow manufacturers to understand the requirements, elaborate and peer review documents and be updated with regulations, guidance and standards.
Remember that Qserve can provide tailored medical writing solutions. If you have any other specific medical writing activity in mind, please let us know how we can help.
In summary, Qserve’s medical writing services will provide you:
- Regulatory precision – experienced in the current regulations for different target markets.
- Scientific accuracy – performed by professionals with a strong background in biomedical and clinical sciences.
- Strategic clarity – documents structured to guide regulators through the scientific rationale applied.
- Efficiency and reliability – on-time delivery with meticulous attention to detail.
Our medical writing services have led to successful regulatory approcal for many start-up and multi-national manufacturers. Please reach out to us for any further information!