Supporting Bibliography for Medical and Diagnostic Devices (REGULATION (EU) 2017/745)

In the field of medical devices, a sustained bibliography is of great help for the dossier (technical, clinical and labelling), according to the type of product and the market of reference.

Studio Gallian offers to realize a supporting bibliography for medical and diagnostic devices. The following logical organization is foreseen in the proposed bibliographies:

Details of the publication: title, author(s), publisher, subject(s), year of publication and reference page(s)
Type and relevance of the source;
– legislative/regulatory;
– professional operators in the sector: doctor – medical researcher or specialist in the sector;
– operational structure of the sector (hospitals, laboratories, etc.);
– professional qualification texts (university texts / school texts);
– competitors;
– suppliers of raw materials, materials and semi-finished products;
– texts, magazines, trade union and commercial publications;
– opinion leaders;
– social networks;
– others (reports, etc.);

Analysis of clinical, technical and biological information identified in the publications

Conclusions in the terms described below:
1. Whereas the article refers to: technical data, clinical data, biological data and/or other data
2. whereas the device analyzed is
– of the same type as the one being examined
– equivalent to the one being examined;
– refers to issues related to the device under examination;
3. it is concluded: that the results are applicable to our device;
3.1 with respect to:
3.1.1. support of the technical aspects of the product (raw materials, manufacturing process and finished product controls, etc.)
3.1.2. Support for preclinical and clinical research (raw materials, manufacturing process, control of the finished product and definition of the residual risks that cannot be eliminated and must be communicated, etc.)
3.1.3. Management of packaging and labelling (materials and communications);
3.2 and therefore confirm:
3.2.1 the activities in relation to the device;
3.2.2 the raw materials used;
3.2.3 the manufacturing process and control;
3.2.4 the risk assessments;
and/or
3.2.5 the above activities are not confirmed and support measures need to be implemented

Studio Gallian offers highly specialized consulting services, accumulated in more than twenty-five years of experience collaborating with important realities in the sector.