Get your software ready for the audit that decides your market entry.
EnvisionArc helps MedTech startups bring software development, quality systems, and data practices up to what MDSAP auditors, notified bodies, and investors will demand. Senior advisory led by practitioners who have sat in the audit as the software lead, backed by a software team with hands-on SaMD development experience.
IEC 62304
ISO 13485
MDSAP
SaMD
Regulatory scrutiny arrives before process maturity does.
Early-stage device and digital health companies build fast, and the development practices that got the product working are rarely the practices an auditor will accept. Requirements live in tickets, traceability is partial, risk files lag the code, and the quality system exists on paper. When the first MDSAP or notified-body audit is scheduled, the gap becomes urgent. We close that gap before the auditor finds it.
Software Quality & Regulatory Readiness Assessment
A fixed-fee assessment of your software development and quality system against what an MDSAP audit will demand. It follows the same model as every EnvisionArc engagement: assess first, then implement, then operate.
- Software development lifecycle against IEC 62304
- Requirements, traceability, and risk management
- Verification and validation practices
- Change and configuration management
- Quality-system integration under ISO 13485
- Audit and regulatory readiness
47
The MDSAP Software Readiness Assessment Instrument
Every engagement is scored against our 47-item instrument, built from direct MDSAP audit experience. You see exactly where you stand, item by item.
You leave with: a scored report, the gaps and risks ranked, and a prioritized remediation roadmap your team can execute.
Advisory that grows with you.
The assessment tells you where you stand. These services carry you from the findings to a quality system that works in practice and a technology foundation that supports the next stage.
Assessment
Technology & Data Health Check
An independent view for leadership on whether your technology and data foundations will support the product, the regulatory pathway, and growth. Architecture, governance, integration, risks, and a recommended roadmap.
Retainer
Fractional Technology & Data Advisor
Senior technology and data leadership on a part-time basis: strategy, architecture decisions, vendor evaluation, data governance, regulatory and quality considerations, and AI adoption.
Training
Training & Workshops
Practical sessions for software, quality, and leadership teams, from software development in a regulated environment to preparing software teams for MDSAP audits and AI governance.
A software team that has developed SaMD.
Our recommendations come from people who have shipped regulated software. EnvisionArc's software team has hands-on experience developing Software as a Medical Device under IEC 62304, so the remediation roadmap you receive is one we know how to execute, and one we can help you deliver.
When the assessment identifies development work, you have the option of a partner who can build alongside your team while your quality system matures.
Practice lead: six years of hands-on SaMD and IEC 62304 work, including MDSAP audit participation as software lead
Quality systems: built and improved software quality programs inside ISO 13485 environments
Development: a software team with direct SaMD development experience
Foundation: more than two decades of data, technology delivery, and team leadership behind the practice
Built for MedTech startups under scrutiny.
Medical-device software companies preparing for a first MDSAP or notified-body audit
Digital health and SaMD startups moving from prototype to regulated product
Teams whose quality system exists on paper and needs to work in practice
Founders who need senior technology, quality, and data judgment before they can hire it full time
Ready to see where you stand?
Know where you stand before the auditor tells you.
Most engagements begin with the fixed-fee readiness assessment. You leave with a scored report against all 47 items and a prioritized plan.