Services
First Of All: Consultancy
There is no doubt that a company that develops medical products or services already has a respectable scientific profile. It produces or sells something it believes in to help patients and improve physicians’ practice.
However, despite the investment of resources and expertise, getting to end customers with the right messages and without missteps may require additional scientific support. The first step of scientific consulting is to look at a product or service, to study it thoroughly, to evaluate it, to grasp its potential, and to suggest the tools needed to enhance it.
The Services
Scientific literature review
To build the bibliography of a product, brochure, or presentation, and to make scientific rationales that can promote the use of a device
Medical device data collection
A product must provide data in order to exist and to succeed. We get this with smart tools and in compliance with regulations and standards.
Paper and report drafting
In collaboration or ghostwriting, any draft stages: design, writing, editing, data analysis. How to enhance the science of your product or service through the most appropriate communication tools.
MDR support for PMS and PMCF
Implementation of surveillance, clinical follow-up, and clinical evaluation plans and reports for the new Medical Device Regulation (EU) 2017/745 in accordance with MDGC guidelines and referenced ISOs.
Dealing with an ethics committee
An ethics committee is always required for the performance of a clinical investigation, i.e., when a treatment deviates from standard of care (pre-market device or off-label use), but it is also mandatory for any scientific publication.
Scientific brochure drafting
Medical devices, supplements, and even services of a scientific nature are all products that require special attention in their communication tools. A scientific brochure takes into account the relevant literature, the state of the art in the market, and the best way to transfer scientific concepts.
