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Medical Device Software Compliance That Accelerates Time-to-Market

Strugglingwith MDR, IVDR, or FDA requirements for SaMD?to align agile development with IEC 62304 and ISO 14971?to manage SOUP, cybersecurity, and continuous updates?to scale your prototype into a compliant, validated SaMD product?

We transform complex regulatory requirements into streamlined systems that get your medical device software to market faster. From AI/ML compliance to cybersecurity frameworks, our life sciences expertise ensures you meet FDA, EU MDR, and ISO standards while maintaining development velocity.

Our Expertise in Medical Devices Software Compliance

Quality Management System Development

Establish a compliant QMS that supports FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements without creating bureaucratic overhead.

Custom QMS development and implementation
Continuous monitoring and management reviews
Internal and supplier audit programs
Quality training and education

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Software Lifecycle Process Implementation

Deploy SOPs and templates that embed ISO 13485, ISO 14971, and IEC 62366-1 compliance directly into your development workflow.

Standard Operating Procedures and integrated templates
Requirements, traceability, and architecture frameworks
SOUP control and tool qualification processes
Gap assessments and audit readiness support

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Risk Management for SaMD/MDSW

Navigate the unique risk landscape of software-based medical devices with a framework designed specifically for SaMD and MDSW, not retrofitted from hardware.

Risk management plan development aligned with ISO 14971
Initial risk assessment and categorization
Risk workshops and mitigation strategy sessions
Living risk management file with continuous updates

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AI/ML Medical Device Compliance

Turn evolving AI/ML regulations into a clear, auditable program that satisfies FDA, EU, and international bodies. We make Good Machine Learning Practices (GMLP) and Predetermined Change Control Plans actually implementable.

Regulatory strategy and pathway development
GMLP implementation and data governance frameworks
Predetermined Change Control Plans (PCCP)
EU AI Act compliance roadmap

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Device Cybersecurity

Build security into your device lifecycle from day one, not as an afterthought. We integrate IEC 81001-5-1, AAMI TIR 57, and ANSI/AAMI SW96 requirements into development workflows.

Cybersecurity strategy and regulatory gap analysis
Security program development and remediation roadmap
SOPs, templates, and compliance documentation
Cybersecurity DHF audit support

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Electronic Quality Management Systems (eQMS)

Transform traditional QMS paperwork into a seamless digital workflow on platforms you already use. We eliminate documentation bottlenecks that delay product launches.

Confluence and Jira-based eQMS implementation
ISO 13485 Section 4.1.6 validation
Workflow automation and templates
Team training and ongoing support

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Trusted by Leading Laboratories

"Our collaboration with wega enabled us to easily implement and validate a very nice, user-friendly and affordable electronic quality management system compliant to ISO13485 and accordingly close a corresponding opened non-conformity. wega also consulted us on how to best document our Software Development in accordance with IEC62304 by leveraging Jira and maintain our technical documentation more easily.
wega also thankfully joined our ISO13485 surveillance audit in the absence of our QARA which was of great help to defend the proper setup of the QMS."

C. Morel, CEO, Axomove

“Our collaboration with wega Informatik enabled us to convert early stage academic documentation into a comprehensive, MDR compliant technical dossier. Their structured V&V plan and thorough testing supplied the Notified Body with the requisite evidence, facilitating CE marking for both PC and VR implementations. The team's expertise in ISO, IEC and ISTQB standards supported our regulatory approvals. wega also delivered a comprehensive workshop on complex regulatory requirements for AI enabled medical devices. Their practical guidance on standards, risk management, and FDA aligned validation accelerated our internal readiness and informed our strategic decisions.”

Charly Leprince, QARA Manager SaMD at Specto Medical AG

"We worked with wega to implement and customize our ticketing system. They delivered a solution that perfectly met our needs. Their comprehensive training empowered our team to manage the system independently going forward. We look forward to continuing this partnership on future projects as our business grows. "

K. Müsch, QARA, 2025

Medical device software companies face a critical paradox: the same regulatory requirements designed to ensure patient safety often become the primary barrier to innovation and market entry.

The real cost of compliance delays:

Extended time-to-market means competitors capture market share first
Regulatory rework costs 3-5x more than getting it right initially
Failed audits damage investor confidence and partnership opportunities

Our approach combines deep life sciences regulatory knowledge with practical software experience. This dual expertise means we design compliance systems that satisfy FDA, EU MDR, and ISO auditors while maintaining your development team's velocity.

What sets us apart:

Native software understanding: We implement compliance on tools your developers already use (Confluence, Jira, modern CI/CD)
Regulatory fluency: Our team navigates FDA 21 CFR Part 820, EU MDR, ISO 13485, IEC 62304, and emerging AI/ML requirements daily
Scalable systems: Whether you're a pre-revenue startup or a multinational corporation, our frameworks scale with your growth
Dual-market expertise: We help you satisfy both EU and US requirements simultaneously, avoiding costly regional redesigns

This is what you can expect:

Companies working with us achieve regulatory milestones faster because compliance becomes integrated into development workflows rather than a separate activity. Your quality system becomes an asset that accelerates approvals, not administrative overhead that slows releases.

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Ready to transform compliance into competitive advantage?

Book a free consultation to discuss your specific regulatory challenges and timeline.
We'll assess your current state and outline a practical path to compliant, market-ready medical device software.

Knowledge Base

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Contact us

Christophe

Managing Director
Board of Directors
CSV & QA