Development

Analysis of the project requirements and drawing up of the product specification
The R&D department collects and prepares the preliminary and detailed specifications of the project and supports the customer while drawing them up in order to quantify the costs and time frames from the very beginning of the project, estimating the product creation price during a series production.

The preliminary specifications prepared by R&D with the help of the internal regulatory department, considering the mandatory applicable regulations based on the nature of the product and generic regulatory standards (eg., environmental, safety regulations, risk management). All of the projects and devices created by Dinamica Generale in the medical field are designed, validated and created to respond to the specific requirements in the industry.

Equipment for the medical industry must comply with qualitative standards that define not only the final performance but also the design and audit process along with safety and risk assessment. In fact, the IEC 60601-1 standards govern the design and manufacture of electromedical equipment and systems through technical standards designed to define their safety and efficacy.

Enforcement of this legislation is a guarantee in terms of basic safety - the absence of unacceptable risks directly caused by physical hazards during normal use or a first failure - and essential performance - those functions defined by the manufacturer whose absence or degradation may represent an unacceptable risk.

Patents
Operating with a company that develops patents like Dinamica Generale ensures dialogue with an organisation that focuses on its commitment to develop solutions in constant progress as well as the availability of the best technology. The internal technical department is staffed with personnel trained in consulting, analysing and preparing patents for the products that have been designed and created for our customers.

The patents certify Dinamica Generale's abilities in research, development and innovation, recognising its efforts and protecting these investments through the ability to generate profit through its talent.

Definition of design
The internal technical department is structured by specifically trained teams for product hardware design (per IEC 60601-1), and firmware and software design and creation (per IEC 62304). The R&D department is structured to prepare the technical file for the product and for the management and validation of revision and product updates.

Risk Management
Dinamica Generale applies ISO 14671 for risk management during the project design phase (mechanical, electronic and software) as well as during the product creation phase (production process) through the use of FMEA techniques.

The FMEA detection method is initially applied during the design phase (for mechanical, electronic and software aspects), where it is possible to systematically identify and assess the consequences of a condition for which a single failure occurs and also detect the possibility of component failure, the risks connected to the design and any improper use by the final user.

The FMEA analysis method is applied during the transfer Design phase to the internal production department for the identification and assessment of assembly and final testing procedures, to identify the insertion of checkpoints and automation to minimise the risk of assembling non-compliant products and for the optimisation of production cycles and cost of the product offered to the customer.

Prototype creation, Verification and Validation
The company is also internally structured to produce prototypes in order to validate product design and performance, simulating operation in the intended use environment (with tests aimed at assessing the performance of the product within the limit of the environmental characteristics required for its application) and the preparation of test reports for the verification of functional and regulatory requirements. The company also has active agreements with specific laboratories that provide support during the verification and validation process.

Dinamica Generale is also focused on the research, creation and maintenance of joint ventures with strategic suppliers throughout the world for the supply of materials for the creation of high performance components from internally prepared specifications (for example, the analysis and design of moulds to create co-moulded plastic or metal components and the analysis and design of dedicated electronic circuits).

Preparation of the technical file
Each system the company creates comes with a Technical File that describes all the choices made, the solution and the problems connected to the device that was developed.