IEC 62304

Medical Device Software Development

Developing IEC 62304 compliant software for medical devices is not a trivial thing. You have to develop software in line with its intended use and compliant with ISO 13485, ISO 14971, and IEC 62304 standards. If you add GDPR and 21 CFR 820 to this equation, you can get easily lost. Work with Pro4People, a IEC 62304 software development partner that knows this domain inside out.

Medical Software Development Company

By choosing Pro4People you’re ensuring:

  • a partner with in-depth knowledge of medical device product lifecycle
  • IEC 62304 compliant software development process
  • meeting ISO 13485, ISO 14971, IEC 62366 requirements applicable to software development
  • instant progress thanks to available templates and working standards about SDLC
  • high quality of the delivered product
  • minimized medical device regulatory risk

Our Experience with ISO 13485 / IEC 62304

Design Inputs

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The goal of this phase is to agree upon what is to be developed in Software Development phase of SDLC. We will create initial plans like Software Development Plan, Configuration Management Plan and Test Strategy. The scope of deliverables will be finalized in the Documentation Index. Also, the initial alignment between Quality Management Systems is usually introduced at this moment. When the Product Requirements are turned into Software Requirements we are ready for the Design Start milestone review and incoming Software Development phase.

IEC 62304 Software Development Life Cycle (SDLC)

Pro4People has defined and managed the IEC 62304 compliant software development life cycle. It greatly simplifies the collaboration as well as minimizes the time required to develop medical device products. Pro4People provides the project team that manages all the complexities of IEC 62304 SDLC. You will work with fully manned team with all the roles available, just to mention:

The use of the &iterative software development life cycle enables your organization to have better control over the incoming releases. Regularly planned project milestones allow your Product Team to make sure that development is continued as planned and that all design outputs are in place.

ISO 13485 Software Verification and Validation

Part of the medical software development life cycle is validation and verification. Pro4People defined the Quality Assurance processes derived from ISO 29119 and ISTQB best practices. All our personnel have adequate competencies confirmed with ISTQB certifications and trainings. As the software development life cycle continues, tests are designed and implemented. On the defined project milestones, tests are executed and the quality and the completeness of the release is evaluated. All the required records are delivered as Design Outcomes.

Design Ouputs


Neil Daly - CEO of Skin Analytics

“We selected Pro4People as a strategic development partner based on their deep understanding of delivering Software as a Medical (SaMD) products. They’ve been engaged, collaborative and an extremely valuable partner. “

Neil Daly
CEO of Skin Analytics

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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 Pro4People may transfer your personal data only to its Trustworthy Suppliers providing supplementary services to us for the purpose specified in this consent.

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