Mission of the organization
Infobiotech designs, develops and prototypes software, hardware, firmware and medical equipment on behalf of companies operating in the biomedical, scientific and electromedical sectors.
The organization operates at the earliest stage of the device life cycle, the stage in which the architectural and technological choices are made that irreversibly determine the safety, the performance and the certifiability of the final product.
From this position stems the responsibility to work according to criteria that make design outputs compliant, traceable and usable by the customer-manufacturer for the purposes of conformity assessment.
Commitment to the safety of end users
Top Management considers the safety of the patient and of the end user to be the overriding criterion in every design choice, even where this entails longer development times or higher costs.
Since Infobiotech operates upstream in the device life cycle, the organization recognizes that decisions taken during design decisively shape the risk profile of the finished product.
Accordingly, Top Management undertakes to:
- integrate the assessment of the risks arising from design choices from the earliest development stages, and not as a subsequent documentary activity.
- take the intended use and foreseeable use error into account when defining the interfaces and the functions of the device.
- develop medical device software in accordance with the life cycle processes defined by IEC 62304, with a documented software safety classification and traceability from requirements to verification.
- subject design outputs to documented verification and validation against the design inputs agreed with the customer.
- ensure that design outputs are produced in such a way as to enable the customer-manufacturer to discharge the obligations laid down by Regulations (EU) 2017/745 and 2017/746.
The value offered to customers
The organization intends to distinguish itself not by its execution capability alone, but by the quality and the regulatory usability of what it delivers.
Top Management therefore undertakes to guarantee its customers:
- An already qualified design supplier: Maintaining an ISO 13485 certified QMS at the design service supplier reduces the supplier qualification and control burden borne by the customer-manufacturer and simplifies second-party audit activities.
- Technical documentation ready for regulatory use: Design outputs are drafted and structured so as to be directly usable by the customer within the technical documentation required by the MDR/IVDR, avoiding downstream rework.
- Integrated multidisciplinary competence: The in-house availability of hardware, firmware, software and system engineering competences makes it possible to manage, through a single point of contact, projects that would otherwise require the coordination of several suppliers, reducing critical interfaces and integration risks.
- Continuity towards industrialization: Design choices are made taking into account the subsequent manufacturability of the device, so that transfer to production is a planned step and not a redesign phase.
Commitment and Objectives of the Management System
The Top Management of Infobiotech S.r.l., represented by the shareholders' meeting and by the CEO, establishes, implements and supports this Management System Policy as an expression of the organization's guiding principles.
Fundamental Principles
Top Management undertakes to:
- Compliance with requirements: Ensure the full compliance of the QMS with ISO 13485 and with all regulatory and contractual requirements applicable to the services provided; the importance of these requirements must be communicated and understood at all levels of the organization.
- Continual improvement: Continually maintain and improve the effectiveness of the QMS through performance analysis, the management of risks and opportunities and the periodic review of processes.
- Availability of resources: Ensure the constant availability of the necessary resources, including competent personnel, adequate infrastructure and a suitable work environment.
Quality objectives
In line with the mission and with the principles set out above, Top Management establishes that Infobiotech's quality objectives are permanently defined in the following areas: 1) Regulatory compliance of design outputs: Ensure that the documentation delivered is complete, traceable and usable by the customer-manufacturer for the purposes of conformity assessment, with no completeness findings during review or second-party audits.
2) Safety and design risk management: Ensure that for every project the risks arising from design choices are assessed and documented and that, for the software component, the safety classification and the traceability required by IEC 62304 are applied.
3) Effectiveness of the design and development process: Ensure compliance with the planning agreed with the customer and the documented control of design changes at every stage.
4) Customer satisfaction: Systematically measure and analyse the level of satisfaction and the complaints received, reducing recurring critical issues over time.
5) Competence of technical personnel: Maintain and increase the technical and regulatory competences of the personnel involved in design, with particular attention to the evolution of the applicable standards.
6) Effectiveness of the Management System: Reduce recurring nonconformities over time and ensure the effective and timely closure of corrective actions.
For each area, the specific objectives, their quantifiable indicators, the targets, the responsibilities and the timescales are defined annually by Top Management in accordance with the arrangements laid down in the procedure "PRO Objectives and Planning for Their Achievement" and formalized in the "MOD Improvement Programme".
Their progress is monitored and reviewed during the management review.
