For over 30 years Kayser Italia has been involved in the design, development, production and testing of systems and components used for scientific and technological research activities on board space platforms, including the International Space Station (ISS), satellites and rocket spacecraft.
In possession of an important transversal know-how, the host company of the second Medical Devices Virtual Talk of SB Solutions has recently shown an interest in the diversification of its business by entering the market of medical devices.
Kayser Italia Story
Q&A: JSB Solutions questions to Kaiser Italy
- How’s the communication going between two realities so far apart?“The first meetings we had had had a very technical cut, surely we highlighted two apparently different languages, however the language becomes simple when you understand the purposes, the method is similar only changes the context in which to apply it.
- Do the two sectors involved, Life Sciences and Aerospace, have different quality standards? Can we say that one of them has a higher level of quality than the other?“Both sectors have very high quality levels, rather than a hierarchy of quality standards we can define a different focus between the two.”
- What are the most challenging aspects and the most satisfying projects? “Working in a company like Kayser is a constant challenge, we have many projects to follow at the same time very different from each other, this is the biggest challenge we face every day. Many are the satisfactions that derive from this work, the publications on scientific journals of international importance are certainly a recognition of the work done that from a great satisfaction, I quote a recent publication about the study of miners bacteria capable of extracting useful materials from the rocks on Mars and the Moon, published in 2020 on “Nature” and “Frontiers in Microbiology” (Space station biomining experiment demonstrates rare earth element extraction in microgravity and Mars gravity”. Charles S Cockell et al., 2020).
Our focus on the new general principles of MDR EU 2017/745
The main changes that will be introduced with the MDR EU 2017/745 can be summarised as follows:
- extension of the scope
- introduction of the person responsible for compliance
- classification rules increased in number, and stricter
- definition of the role and responsibilities of the Economic Operators involved in the import and distribution of medical devices: Manufacturer, Authorised Representative, Importer and Distributor. For each of these subjects specific requirements are foreseen. Greater importance to the Clinical Evaluation
- stricter post-marketing surveillance and surveillance
- more technical documentation to be produced
- device traceability with the creation of the UDI (Unique Device Identification) system
- use of EUDAMED to collect device information in a single European database.
With the new EU 2017/745 regulation, the manufacturers of medical devices will have to present a technical documentation, to obtain the certification or to renew an existing one, much more substantial than in the past. This documentation shall include the following points:
- description and specification of the MD, including accessories and variants
- information to be provided by the manufacturer
- design and manufacturing information
- general safety and performance requirements
- risk and benefit analysis and risk management
- product verification and validation, including clinical evaluation
- for Class I DM, manufacturers shall provide a periodic safety update report (PSUR). For Class Iib and III DM, the PSUR shall be updated at least once a year, and for Class Iia at least every 2 years. Except for tailor-made Msds, for which the PSUR is part of the technical documentation.
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