Medical Writing is not just about clear language, it concerns translating science and compliance into approval-ready documentation. You already know the importance of this activity and how Qserve can help you to get regulatory approval with our modular services (if not, check out our blog about modular medical writing). However, you may still question how it fits into your organization, and you are not alone!
Below are the top 5 questions MedTech companies ask before outsourcing medical writing, and Qserve’s answers for them.
1. Do you understand the regulatory requirements and standards?
Qserve is well known as the go-to consultancy regarding CE marking (MDR). However, what you may not be aware is that we have a global team fluent in different languages that is based not only in different countries of the EU, but also in the United States, UK, China and Brazil. In addition, we are represented in several ISO Technical Committees, such as TC 194 – Biological and Clinical Evaluation of Medical Devices, responsible for ISO 10993 series, ISO 14155 and the upcoming ISO 18969. This combination allows our medical writing team to be updated in the current regulations and standards worldwide.
2. What experience do you have with our type of medical device?
Our medical device team has experience in a variety of medical devices, including those for general purposes (hospital beds, chairs) and temperature management, disposables and instruments, combination products, devices for wound care, high-risk devices, software and devices without medical purposes. It has successfully covered different medical fields such as cardiovascular, neuroscience, ophthalmology, orthopedics, diagnostic imaging, dental, gastro-enterology, urology, respiratory care and oncology.
3. How do you ensure quality, accuracy, and consistency across technical documentation?
Qserve presents certification ISO 9001, the international standard for quality management system (QMS), which is evidence that we consistently meet customer and regulatory requirements. Our medical writing process is fully peer reviewed and has version control of well-structured documents.
4. Can you help us handle gaps in our existing data or legacy documentation?
Our medical writing team has helped dozens of manufacturers during the transition from MDD to MDR, making us experts in handling gaps and legacy documents. This experience allows us to have a strong understanding of how to use existing data to its fullest. We have also helped many clients leverage data from other countries such as China and the United States for CE marking in Europe.
5. What's your turnaround time, and how do you manage communication and collaboration?
It is not linear predicting how long the medical writing activities will take, as it depends on the nature of the activity itself, on the inputs provided, on existing data and on the wished deadlines. However, we can assure you that we will manage timelines with structured milestones and transparent communication, and that every draft will be reviewed and delivered as scheduled, without surprises.
Final Remarks
Qserve’s Medical Writing is not just writing. It is scientific knowledge translated into regulatory requirements that will help you to build a coherent and compliant story that is able to fully support the safety and performance of your medical devices. Contact us for any further information.