Development for Regulated Industries
Specialized software development services for industries with strict regulatory requirements. We deliver compliant, secure, and auditable solutions that meet the highest standards of regulatory compliance.
Regulated Industries Overview
Developing software for regulated industries requires deep expertise in compliance frameworks, security standards, and regulatory requirements. VNcent brings years of experience working with healthcare, pharmaceutical, financial services, and other highly regulated sectors.
Our team understands that compliance isn't just a checkbox—it's a fundamental requirement that must be built into every aspect of the development process. From initial design through deployment and maintenance, we ensure your software meets all applicable regulatory standards.
With certifications including ISO 27001, ISO 9001, and ISO 13485, we have the credentials and experience to deliver software solutions that pass regulatory scrutiny while meeting your business objectives.
Compliance Frameworks
ISO Standards
- •ISO 27001: Information Security Management
- •ISO 9001: Quality Management Systems
- •ISO 13485: Medical Device Quality Management
Industry Regulations
- •FDA Regulations (21 CFR Part 11, 820)
- •HIPAA: Healthcare Data Protection
- •SOX: Financial Reporting Compliance
- •PCI-DSS: Payment Card Industry Standards
Security & Data Protection
Security is paramount in regulated industries. We implement comprehensive security measures including encryption at rest and in transit, secure authentication and authorization, audit logging, and regular security assessments.
Data Encryption
- •AES-256 encryption for data at rest
- •TLS 1.3 for data in transit
- •Key management and rotation
Audit & Compliance
- •Comprehensive audit logging
- •Regulatory documentation
- •Compliance reporting and validation
Regulated Development Process
Our development process for regulated industries incorporates compliance requirements from day one. We follow a structured approach that includes:
- Compliance-First Design: Regulatory requirements are integrated into the architecture and design phase, not added as an afterthought.
- Documentation & Traceability: Comprehensive documentation that demonstrates compliance and enables regulatory audits.
- Validation & Testing: Rigorous testing protocols that validate compliance requirements and ensure system reliability.
- Change Management: Controlled change processes that maintain compliance throughout the software lifecycle.
Industry Specializations
Healthcare & Pharma
Specialized development for medical devices, healthcare applications, and pharmaceutical systems. ISO 13485 certified with deep expertise in FDA regulations and HIPAA compliance.
Financial Services
Banking, fintech, and financial services development with expertise in SOX compliance, PCI-DSS standards, and financial regulations. Secure, compliant financial systems.
Need Compliant Software Development?
Contact our regulated industries team to discuss your compliance requirements and development needs.