Medical device software remediation for market readiness
If your existing software needs to progress toward MDR- or IVDR-aligned market readiness, we assess what is already in place, identify what needs to be completed or improved, and implement the agreed medical device software remediation activities.
Why do medical device companies work with us?
Medical device companies work with us when existing software needs a structured medical device software transition into a regulated development environment.
Our engineering, QA, regulatory, and product design specialists assess existing systems, identify technical, quality and documentation gaps, and deliver medical device software remediation activities aligned with IEC 62304, IEC 82304, ISO 14971, and IEC 62366.
Does your software need support before market entry?
If any of these sound familiar, medical software remediation can help you move forward.
You’ve a working app, but your current supplier lacks medical device software experience
Regulatory requirements were introduced after development had already started
Software lifecycle documentation is incomplete, inconsistent, or missing
You’re unsure what needs to be completed before an audit
You need to determine whether the existing software can be adapted as a medical software
A notified body or auditor identified major gaps
Technical debt, outdated dependencies, or architectural decisions are limiting your development
You need a reliable estimate of the work, cost, and ownership required to move your project forward
Our medical device software transition services
Technical assessment of your system
Quality assurance gap assessment
Software lifecycle & documentation gap analysis
Quality Management System (ISO 13485) integration readiness
Medical software remediation and regulated development
Technical assessment of your system
Get a clear understanding of your software’s current technical condition and which technical issues must be addressed before the project can progress.
Our medical device software gap assessment covers architecture, code, cybersecurity, dependencies, and technical debt, providing recommendations, recovery options, and next steps. Receive a prioritised overview of technical gaps, risks, and recommendations to help you make informed business decisions.
Quality assurance gap assessment
Determine whether your medical software is ready to progress toward market entry.
We assess critical user flows, application stability, verification risks, and product quality to identify defects and gaps that may affect certification. You receive an overview of the product’s current quality, a prioritised defect and gap matrix, remediation recommendations, and an estimate of the effort required to improve product quality and reliability.
Software lifecycle & documentation gap analysis
Identify which software lifecycle records already exist, which can be repainted, and which need to be completed or reconstructed to support conformity assessment activities.
We review available software documentation and development records in relation to applicable requirements of IEC 62304, ISO 14971, IEC 62366, and MDR or IVDR to identify missing elements and compliance risks. You receive a matrix outlining missing or inconsistent records, the impact of each gap, and required actions.
Quality Management System (ISO 13485) integration readiness
Prepare your software for effective integration into your quality management system.
We review how software-related activities connect with your QMS, including requirements management, change control, risk management, verification, and maintenance processes. You receive recommendations on responsibilities, missing records, and dependencies between the software remediation work and your quality framework.
This scope doesn’t constitute a complete ISO 13485 certification audit or full QMS implementation.
Medical software remediation and regulated development
Turn the approved plan into a controlled medical device software remediation process with clearly defined priorities, responsibilities, and delivery stages.
Depending on the assessment results and agreed scope, we can complete or improve software lifecycle documentation, resolve critical software defects, remediate technical debt, and address cybersecurity risks.
The implementation scope is defined only after the assessment. This allows both parties to agree on realistic responsibilities, costs, timelines, risks, and acceptance criteria.
Not sure what your software needs before market entry?
Before investing further in development, understand what is blocking your progress. Discuss your project’s needs and requirements with our engineering and regulatory experts.
What you get working with us
By the end of the assessment, you’ll receive a comprehensive medical device software market readiness plan, including:
an executive summary of the product’s current status
technical condition assessment
software lifecycle and documentation gap analysis
quality and app stability review
list of next steps (must, should and nice-to-have actions)
estimated costs and timeline
available remediation options,
roadmap toward certification readiness.
How do we work with you?
We serve as your critical medical software supplier within your quality and regulatory framework, while you remain the legal manufacturer responsible for the device.
Our multidisciplinary team assesses your software and delivers medical device software remediation activities aligned with MDR, IEC 62304, ISO 14971, and IEC 62366, adapting the approach to your product’s specific needs.
Case study
Check out how we work through real-life projects:
About Revolve Healthcare
A partner for the next stage of your medical software
We help medical device companies move existing software products from standard application development into a regulated market-entry pathway.
Combining software engineering, QA, product design, and regulatory expertise, we assess existing products, identify compliance gaps, and create practical roadmaps toward CE certification.
With an ISO 13485-certified QMS and experience across MDR- and IVDR-aligned projects, we help organisations retain valuable existing work, reduce uncertainty and make informed decisions about the next stage of their medical software.
Move your existing medical software toward market readiness.
During a free 45-minute call you will:
discuss your current project status and learn challenges of your project
understand the key MDR, IVDR, quality, and technical requirements
get initial answers about the feasibility and next steps of moving your software toward market entry.