What I can do
Medical device CE mark
Last May 2021, the European Directive 93/42 ceased to be valid and for the manufacturing and marketing of any medical device, from simple surgical masks to the most complex respirators, it is necessary to adapt the technical file, manuals, risk analysis according to ISO 14971 and declaration of compliance with the new regulation 2017/745. I am able to assist you in the preparation of all the necessary documentation and I can act as an intermediary with test laboratories and notified bodies.
Person Responsible for Regulatory Compliance PRRC
The new 2017/745 Medical Device Regulation requires the appointment of a person responsible for compliance with the regulation who takes charge of the verification of all company processes relating to the design and manufacturing of medical devices.
I can help you with the preparation of effective procedures and possibly, if your company is not obliged to have an internal one, I can be your responsible person according to the new medical devices regulation.
Company management system
A ISO 9001 or ISO 13485 compliant quality management system is required more and more often. I can become your external consultant for the quality management system; I will make sure that all company processes comply with the standards. It will be my responsibility to fill in all the necessary forms and carry out internal audits so that what is written on the documents corresponds to the actual company dynamics.
Moreover, I can prepare all the documentation relating company safety as required by D. L. 81/08 and possibly offer an external RSPP service.
Electronic and mechanic design
Electronics and mechanics are now strongly related in the industrial world.
Using 3D CAD design platforms, I can carry out feasibility studies and development of components and circuitry designs, as well as manage and monitor any assembly tests.
In addition, using reverse engineering, I can digitize objects in real time and turn them into 3D files that you can import in any CAD software.
Rapid prototyping
This is not a classic 3D printing service: I can point you to the best technology to use according to your requirements: traditional 3D printing, 3D laser printing, creation and management of silicone molds for small series, CNC prototyping.
In addition I am also able to manage the realization and the assembly of electronic circuits.
Training
I can prepare training courses on electrical safety, company safety, programming, electrical engineering and Microsoft products.
Courses are intended both for professionals who want to keep up to date and for children who are not satisfied with the info learned at school and who want to touch what they have studied.