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Medical Writing for Medical Devices and In-vitro Diagnostics

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.

Clinical Evaluation

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.


Clinical Evaluations according to MDR requirements

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


Stage 0:
Scoping Plan

Outline the objective of the clinical evaluation and definition of intended use

Data Identification

Collection of all relevant data required for the clinical evaluation

Stage 2:
Data Appraisal

Data evaluation and verification of the data sources

Stage 3/4:
Data Analysis & Clinical Evaluation

Assessment of all relevant data and preparation of a clinical evaluation report on the assessment


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.


Performance Evaluation of In-vitro Diagnostics

 Performance Evaluation

 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.


Customer Feedback


"ISS supported us in the processing of the clinical evaluations and the change of the product labelling in the context of MDR. We have received very competent and solution-oriented support. We will also be happy to work with ISS in future projects."




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.

Medical expertise

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