Technical audits
and compliance.
Verify your system, before the market does
Technological certainty before a key decision
Certification, investment, or product scaling require a reliable assessment of its technology and compliance with regulations. At itCraft, we conduct independent audits of code, architecture, and compliance for medical solutions and systems processing sensitive data. We provide a clear report that precisely identifies risks and their impact on the stability and security of your business.
When does an audit become crucial for business?
Technological problems and regulatory non-compliance rarely reveal themselves when they can be easily fixed. They usually strike at moments when certification, financing, or security is at stake. We support you at these critical stages.
Certification preparation
Transaction and Due Diligence
System takeover and development
Cyber threat risk
We do not limit ourselves to general conclusions. Our audit is a deep verification of technology and compliance, divided into key engineering and regulatory areas.
We check the quality, cleanliness, and maintenance of the source code, identifying technical debt. We assess the system structure, API performance, and the completeness of documentation and traceability of requirements.
We analyze vulnerabilities of applications and open-source components. We verify access control mechanisms, cloud configuration, backup procedures, and resilience to modern attack vectors.
We examine software compliance with guidelines for the regulated software market. We verify the criteria of medical and legal standards: MDR, HIPAA, GDPR, and ISO 27001 and 13485 standards.
We assess the completeness of audit documentation and the compliance of production processes with the requirements of notified bodies. We identify formal gaps before external certification.
Audit methodology step by step
We conduct the process in an orderly, transparent, and independent manner to provide a complete picture of the situation without disrupting your development team’s daily work.
Context and goals analysis
Technical review (Assessment)
Risk and non-compliance identification
Expert report and remediation
Decisions based on facts, not assumptions
After completing the work, you receive a full, practical picture of the technological and legal situation of your system. You gain hard data for product management.
Clear picture of priorities and regulatory readiness
You gain precise knowledge about the system’s condition, allowing you to accurately plan development budgets and eliminate risks before they affect business stability. You know exactly whether the product is optimally prepared for certification (MDR, HIPAA, ISO) and due diligence processes before a funding round. An independent audit provides hard data that allows management to make decisions without uncertainty.
Certainty in key moments
Before an external auditor enters, you precisely locate and remove formal and technical gaps. You know and eliminate non-compliance before they are officially recorded in the certification process, protecting the project from costly delays.
During talks with investors, you gain hard evidence of code cleanliness and architecture security, significantly speeding up valuation and closing the round. Before signing enterprise agreements, you prove to business partners that their data will be processed in a stable environment.
Security and foundation for scaling
You receive clear guidelines on how to prepare IT architecture to handle dynamically growing traffic without accumulating technical debt. Implementing audit recommendations optimizes cloud infrastructure maintenance costs, ensures long-term legal compliance, and significantly increases the digital resilience (cyber-resilience) of the entire ecosystem.
Regulated software experts
We combine years of experience in software engineering with practical knowledge of the specifics of demanding environments where safety, quality, and regulatory compliance are critical to product success.
Working with us means:
- Experience in regulated industries: Years of developing and auditing advanced systems for Healthcare, MedTech, FinTech, and Logistics sectors.
- Standards confirmed by certificates: As an organization, we operate based on implemented quality and security management systems: ISO 27001 and ISO 9001.
- Practical knowledge of requirements: We translate theoretical MDR, HIPAA, and GDPR regulations into real engineering criteria and specific lines of code.
- Interdisciplinary team of experts: We combine the competencies of architects, senior developers, QA, and security and compliance specialists within a single project.
- Recommendations ready for implementation: We do not theorize. We provide programmers with precise technical guidelines that can be immediately introduced into the sprint.
We do not only provide a list of problems. We deliver a plan to organize technology that supports product development and reduces business risk.
Verify the system
before the audit
If you are preparing a product for certification, investment, or further scaling, an earlier independent technological assessment allows for faster decision-making and reduces the risk of costly delays. Let's talk about your project. We will analyze its specifics and select the scope of the audit that will truly support the development of your product.
