IT Solutions Provider
Excellence From the First Bit
Pro4People is a software house specializing in development and maintenance of innovative IT solutions. We have been implementing modern and secure IT products for a global market. We’re experts in developing products like: medical devices, connected health solutions, web applications, cloud backend services, SaaS platforms, mobile applications, Internet of Things solutions, and Artificial Intelligence. As an Amazon Web Services (AWS) Consulting Partner we help clients in porting their solutions to AWS Cloud. Finally, we offer regulatory consultancy along product and software development life cycles.
SOFTWARE DEVELOPMENT
Efficient development of medical device software compliant with EU and FDA regulations as well as non-regulated IT products. With our cross-functional R&D teams, unique technical expertise, and proven Software Development Life Cycle (SDLC), we’ll develop a tailored innovative solution for you. You’ll work with our experts in areas such as Software As a Medical Device, cloud computing, Artificial Intelligence, web and mobile applications, Internet of Medical Things, and system integration. Compliance with ISO 13485, ISO 14971, IEC 62304, MDR, GDPR and 21 CFR 820 will be assured.
ISO 13485 – QUALITY MANAGEMENT SYSTEM
For theses of the clients who require a supplier to follow ISO 13485, 21 CFR 820, or MDR regulation it is important that Pro4People operates under ISO 13485 certified Quality Management System (QMS). Our QMS was certified by Lloyd’s Register (ISO 13485 – 00022249) for “Design and development of medical device and health software for medical device manufacturers”. Additionally, we operate under integrated and certified ISO 27001 Information Security Management System (ISMS) and IEC62304 compliant Software Development Life Cycle (SDLC) management system. All theses systems managed on secure and user-friendly ins2outs.com platform.
AWS CLOUD SOLUTIONS
As an AWS Consulting Partner we can help you to bring your IT infrastructure into the AWS cloud or other cloud provider. This way you can lower the costs of your IT infrastructure, make your IT service available globally, highly scalable, and significantly improve your overall system security and reliability. We design the architecture, plan availability, as well as provide the costs structure of your final IT AWS cloud-based solution. We help you to meet at the same time all regulatory requirements with e.g. hybrid cloud architecture in respect to regulations such as GDPR, CCPA, HIPAA or ISO 27001 standard.
BUSINESS CONSULTING
Nowadays, when launching new products, organizations are quite often challenged with the need to fulfill regulatory requirements. We can assist your organization in the definition, execution and certification of management systems in the domains such as: ISO 13485, ISO 14971, IEC 62304, ISO 27001 or HIPAA . We offer a full consultancy project from the beginning to successful completion/certification just within weeks. All projects are delivered on a secure and easy ins2outs platform which helps your organization to meet regulatory requirements. Our benefits are: ins2outs as a SaaS platform, practical engineering approach, availability of predefined know-how sets and extremely short time to certification.
IT INFRASTRUCTURE MANAGEMENT
We provide the 2nd level of support to your AWS cloud deployed IT systems. The goal of this service is to maintain your existing IT solutions based on cloud and to keep them operational, secure and accessible. Pro4People offers the formation of the IT Teams, aka service delivery teams, responsible for providing the 2nd level of support to your existing IT solutions. We will define, document and execute all operations activities specified and required by ISO 27001 standard and privacy regulations. Your infrastructure will be monitored, maintained, and updated regularly following mutually agreed Service Level Agreement.
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