IEC 62304 Medical Device Software Development

Medical Device Software Development

Developing IEC 62304 compliant software for medical devices is not a trivial thing. You have to in effect 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 IEC 62304

Work with a medical device software development partner that understands medical device regulations. Our employees participated in the development of medical devices up to Class IIb and B software safety classification.

We have taken part in implementation and coordinating the certification of ISO 13485 quality management systems. Use our well-defined, evaluated and proven IEC 62304 compliant software development life cycle (SDLC). All of that neatly available and internalized in the organization thanks to ins2outs – a quality management system.

You have no idea what we are talking about? Please refer to our Business Consulting Services to bring that know-how into your organization as well.

Design Inputs

When we start working on a medical device project, there is certain scope of information that will be required for tailoring IEC 62304 compliant software development process. The input would thus consist of:

  1. Medical device intended use
  2. Medical device classification
  3. Medical device regulatory strategy
  4. Product requirements

That input will be subsequently used to understand the regulatory context of the new development project.

Learn how Pro4People can help you
in Medical Device Software Development

 

 

 

Pre-development

The goal of Pre-Development 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 as well as Test Strategy. The scope of deliverables will be subsequently 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 as well as 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 and also minimizes the time required to develop medical device products. Pro4People provides the project team that manages all the complexities of IEC 62304 SDLC. As a result, you will work with fully manned team with all the roles available, just to point out:

In essence, 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.

Learn how Pro4People can help you
in IEC 62304 Software Development Life Cycle

ISO 13485 Software
Verification and Validation

Part of the medical software development life cycle is validation and verification. With this intention Pro4People defined the Quality Assurance processes derived from ISO 29119 and ISTQB best practices. All our personnel have adequate competencies confirmed with ISTQB certifications together with trainings.

As the software development life cycle continues, tests are designed and implemented. On the defined project milestones, tests are executed and as a result the quality and the completeness of the release is evaluated. All the required records are after that delivered as Design Outcomes.

Design Ouputs

As soon as a new software Release Package has been verified with SDLC, a new set of deliverables is prepared for design transfer. These deliverables are then transferred, in a secure manner, to the team responsible for Solution Providing product phase. The set would usually consist of:

  1. Release Package
  2. Release Notes
  3. Test Plan, Test Levels Specifications, Tests Execution Summary Report
  4. Manuals for installation, deployments, as well as operations activities
  5. Documentation and records as specified in the Documentation Index

That Design Outputs will be subsequently used by the Solution Providing team to plan for reviews, transition and validation activities.

Learn how Pro4People can help you
in Medical Device Software Development

 

References

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 Device (SaMD) products. They’ve been engaged, collaborative and an extremely valuable partner.

Neil Daly
CEO of Skin Analytics
https://skin-analytics.com/

Skin Analytics

Dr David Cox - Chief Digital Officer & Co-founder of Closed Loop Medicine Ltd

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
https://www.closedloopmedicine.com/

Closed Loop Medicine Ltd

Tash Thirkell, Operations Manager at ARC Microtech

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.

Tash Thirkell
Operations Manager at ARC Microtech
arcmicrotech.com

ARC Microtech

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:

info@pro4people.com
+48 726 700 113
+48 602 148 253

Our office operates from 8:00 to 17:00 CET.