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.
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.
We selected Pro4People as a strategic development partner based on their deep understanding of delivering Software as a Medical Device (SaMD) products. They’ve been engaged, collaborative and an extremely valuable partner.
CEO of Skin Analytics
The team at Pro4People are great to work with. They are professional, flexible and have a huge amount of experience in developing SaMD, so are able to offer a good balance of direction and pragmatism when it comes to developing software under a QMS, whilst holding your hand through the process if it’s not something you’ve done before.
Dr David Cox
Chief Digital Officer & Co-founder of Closed Loop Medicine Ltd
Pro4People independently reviewed, tested and validated our Medical Device Software to IEC 62304. Working to a very tight deadline, Pro4People’s experience was invaluable and their diligent and supportive team a pleasure to work with.
Operations Manager at ARC Microtech
Pro4People is driving our software development since the early stage of our venture. We were able to grow with them through the different maturity stages from MVP to a multi-sensor and multi-frontend (web / mobile) IoT platform. Great project control and documentation, impressive AWS knowledge and system compliance and security focus are definitely the strength of Pro4People.
Co-Founder, CTO of Qlair
Pro4People works for STREAMETRIC as a software development vendor since the beginning of 2019. Since then, their agile and cross-functional team provides us UI/UX design, software development, DevOps, business analysis and project management services with the highest level of quality. Compared to other software development providers, Pro4Peoples especially distinguishes with their structured procedures and discipline in documentation.
Head of STREAMETRIC, a MANN+HUMMEL corporate startup
At qlair we couldn’t ask for a better team to support our development activities from early stages of our company. We worked with a team of experienced developers, creative designers, thoughtful business analyst, and professional project manager at Pro4People. We were impressed by the quality of service we received in every stages of our development work and learned a lot about team structure, documentation, development process and quality testing. Looking forward to grow our platform with the help of professionals at Pro4People.
As Video Technologies partners, Pro4People has been a dedicated and talented ally in our ability to expand our services and provide clients with top video streaming capabilities. Always team players and always on their game, they are a gratifyingly essential part of what we do.
CTO of Bedrocket Media Ventures
Let’s talk about your project
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