Excellent IT Solutions
for MedTech and IVD
Pro4People is a software house specializing in the development and delivery of innovative IT products for the global MedTech / IVD markets. We develop medical devices (MD), in vitro diagnostics (IVD) medical devices, the Internet of Medical Things (IoMT), cloud services, web and mobile applications. We offer IT infrastructure management and the delivery of launched cloud-based solutions, as well as quality, regulatory, and security consulting required to put a product on the market.
MEDICAL DEVICE SOFTWARE DEVELOPMENT
The development and maintenance of regulated software for MedTech and IVD has been one of Pro4People’s main services since 2013. We offer the IEC62304 compliant Software Development Life Cycle (SDLC) process for such systems as: the Internet of Medical Things (IoMT), cloud backend systems, web portals, mobile applications, and finally Artificial Intelligence (AI)/Machine Learning (ML) solutions. We develop up to Class C of software safety classification and Major Level of Concern systems to all the global regulatory regimes. Thanks to our unique experience in the clinical, SDLC, and regulatory domains we can deliver the first version of a Software as a Medical Device (SaMD) in just a couple of months.
Medical Domain Expertise
To design and develop a reliable MD or IVD software, it is crucial that your development partner has the in-depth medical domain expertise. Our clinical domain experience clearly sets Pro4People services apart from other offerings.
Systems
Treatment
Diagnostic System
Telemonitoring
Monitoring
Things
Solutions
Information System
Collection
Management
IT INFRASTRUCTURE MANAGEMENT AND SERVICE DELIVERY
When the development is finished and SaMD is put on the market, its delivery needs to be addressed on several levels: cloud, operational, quality and security. Pro4People can take the responsibility for maintaining your production environments and keeping them operational. We provide the second level of technical support to your cloud deployed IT infrastructure. Then, we plan and execute all required validation activities. Finally, our team operating under Pro4People QMS can assure the compliance with all the applicable regulations and standards like ISO13485, ISO27001, GDPR or HIPAA. Thus, your organization can provide cloud deployed SaMD products in an uninterrupted, compliant, and cost-efficient manner.
ISO 13485 QUALITY MANAGEMENT SYSTEM (QMS)
Manufactures of medical devices should collaborate only with certified suppliers to minimize their products’ regulatory risk. Pro4People provides all its services under the ISO 13485 compliant Quality Management System. Pro4People’s QMS certification covers full IT product life cycle: “Design and Development and Service Provision of medical device and health software for medical device manufacturers”. The certification was issued by Lloyd’s Register (ISO 13485 – 00022249). Pro4People integrated QMS extends also to other harmonized standards and such regulations as MDR, IVDR, 21 CFR 820, GDPR, HIPAA, IEC62304, ISO14971, IEC62366 or ISO27001.
AWS CLOUD CONSULTING
Pro4Peope, as an AWS Consulting Partner, can help you to bring your medical device software to the AWS cloud or other cloud providers. This way, you can lower the costs of your IT infrastructure, make your SaMD service available globally, leverage cloud-based risk control measures, and significantly improve your overall system security and availability. Our architects can design the architecture, plan availability, predict delivery costs, and provide installation and operations scripts. At the same time, we can design your system to meet any regulatory requirements like GDPR, HIPAA, ISO27001 or national regulations. Consequently, your organization can execute a medical device digital strategy.
QUALITY, REGULATORY, AND SECURITY CONSULTING
To develop and provide a Medical Device, or In Vitro Diagnostics Medical Device, on any market, an organization must fulfill specific regulatory and quality requirements. Pro4People offers expert regulatory consulting in the domains of medical devices (MDR, 21 CFR 820), in vitro diagnostics medical devices (IVDR), and the following harmonized standards: ISO13485, ISO14971, IEC62304, IEC62366. We help our clients to define and certify their Quality Management Systems (QMS), put their products on the market (CE marking, 510(k) submission), or to define and execute a product regulatory strategy. Pro4People also offers consulting on ISO27001 – Information Security Management System; all of that on our online regulatory ins2outs platform.
Let’s talk about your project
Information Note
Pro4People sp. z o.o., based in Wrocław, Poland at Wołowska 18 (postal code 51-116), will be the controller of your entrusted personal data. Your personal data will be processed for the period of 3 years from the moment of the last contact. Your data will be processed under the General Data Protection Regulation (GDPR) and derived Polish national regulations. The base for processing is your consent, thus you can execute all the individual rights derived from GDPR at any moment by contacting us at gdpr@pro4people.com. Pro4People may transfer your personal data only to its Trustworthy Suppliers providing supplementary services to us for the purpose specified in this consent.
Pro4People
If you prefer to reach us directly, you can send us an email or call us:
+48 663 466 030
Our office operates from 8:00 to 17:00 CET.
© 2013-2021 Pro4People Sp. z o.o. All rights reserved. Legal Notes
