Professional medical writing is essential when you bring medical devices or In-vitro Diagnostics to market. Our experienced specialists offer expertise in medical writing, clinical know-how, and updated regulation to prepare compliant regulatory documentation.
Creating a high-quality clinical evaluation that meets MDR requirements can be a time-consuming, cost-intensive and complex task for medical device manufacturers. This is exactly where we can provide efficient and individualized support. Our experts have extensive industry knowledge and years of experience to ensure that your regulatory documents are fully compliant with MDR requirements and that your medical devices receive market approval.
Introduction of the MDR has led to substantially greater hurdles to achieving and maintaining regulatory compliance, particularly in context with clinical evaluations and clinical data requirements. New guidance to further clarify these requirements continues to be released in the form of MDGC documents, while Revision 4 of the MEDDEV 2.7/1 guideline remains valid in parts. This has created a complex and dynamic regulatory environment that can be hard to follow for manufacturers. Due to our in-house knowledge management and many years of experience in clinical evaluation planning and writing, ISS offers state-of-the-art clinical evaluations that comply with the newest regulatory requirements.
Creation of a clinical evaluation in several steps
Data Analysis & Clinical Evaluation
The MEDDEV. 2.7/1 Rev. 4 defines clinical evaluation as a process in 5 phases (stages 0 through 4). Our approach and the associated templates are based on this phase model. We carry out the projects in phases to ensure that risks and gaps in clinical evidence are detected early and that appropriate measures can be taken. In the scoping/planning phase (stage 0), we work closely with technical and regulatory experts of your company to determine the best clinical evaluation strategy. This phase can also provide valuable inputs for products that are still under development, as the clinical strategy is one of the key factors affecting time to market and development costs. Depending on your needs, we are happy to support you in specific phases of the clinical evaluation process.
The introduction of the IVDR has also greatly increased the regulatory requirements for In-vitro Diagnostics, especially in the area of performance evaluation. We prepare your performance evaluation according to IVDR requirements, develop an evaluation strategy, or review your existing performance evaluation taking into account the latest regulatory requirements and our experience with feedback from Notified Bodies.
Medical Writing Projects
Years of experience
Countries, where we register medical devices
ISS AG employees
Our Medical Writing team consists of several experts with various life science backgrounds and expertise in basic and clinical research techniques, literature review methodology, and biostatistics. Our team has experience from over 200 clinical evaluations, covering a wide range of medical fields and different technologies, and our learnings from cooperating with Notified Bodies and authorities in Europe and worldwide are applied to continuously improve our processes.
We have a network of specialists from various disciplines. Currently we can cover the following medical specializations with our own medical experts: ophthalmology, odontology, traumatology, and orthopedics. We seek expert advice from other disciplines on a situational basis.
We put your needs first and do our best to provide you with reliable services tailored to your needs. Our happy customers testify to the professional and high-quality support they received from us also in times of high pressure.
Dr. Kathrin Abegg
Tel. +41 32 513 6767 | Mail
Team Leader Medical Writing