Security at Regdesk
Trust is the Foundation of our Platform
Trust powers regulatory operations for global medical device and diagnostic companies. We handle sensitive information including product data, regulatory submissions, and market strategies and are committed to ensuring its confidentiality, integrity, and availability at all times.
Our Security Program
We follow industry best practices and frameworks to maintain a secure, compliant, and resilient environment.
Data Encryption
All customer data is encrypted in transit and at rest using modern cryptographic standards (e.g., TLS 1.3 and AES-256).
Access Controls
Role-based access ensures only authorized users can access sensitive data. Multi-factor authentication (MFA) is enforced for all internal users.
Monitoring & Detection
We monitor systems continuously to detect and respond to threats, using automated alerts and 24/7 incident response protocols.
Regular Security Audits
We conduct regular internal and third-party security audits to evaluate and strengthen our controls.
Password Protection
We store all passwords in encrypted format.
Backup & Recovery
Regular backups and replication for automatic failover.
Logical Data Segregation
Customer Data is isolated in separate AWS-based storage containers for single-tenant servers.
Fully Redundant Architecture
We use AWS instances in Germany with backups in Ireland to ensure we meet the GDPR data residency requirements related to data transfer requests outside the European Economic Area (EEA).
Use of Third Party Providers
We partner only with reputable cloud service providers and infrastructure vendors who meet the same rigorous standards we uphold. All third-party vendors undergo strict due diligence and are contractually bound to meet data protection requirements.
Third-Party Penetration Tests
Annual security tests by certified assessors.
Vendor Compliance Review
All vendors undergo rigorous review and approval.
Continuous Risk Monitoring
Ongoing assessment of threats, vulnerabilities, and mitigation plans.
Certifications & Compliance
RegDesk is committed to maintaining the highest standards of regulatory and data security. Our platform and operations align with globally recognized standards, including:
SOC 2 Type II Certified
Annual third-party audit covering security, availability, and confidentiality.
ISO 27001 Certified
Global standard for information security management systems.
GxP Compliance
Supports Good Practice guidelines including audit trails and electronic records.
FDA Compliance
Built for life sciences regulatory teams, aligned with 21 CFR Part 11.
GDPR & CCPA
Full adherence to data privacy laws for global users.
We also support our customers’ compliance with other region-specific medical device regulations, including FDA, EU MDR, and MDSAP requirements.
Corporate Security
Device & Endpoint Management
Enforced on all employee devices.
Least Privilege Access
Default permissions are intentionally designed to be minimal needed access and all access is reviewed regularly.
Physical Security
Badge-access controls at all RegDesk office locations.
Transparency & Responsibility
At RegDesk, protecting our customers’ data is at the core of everything we do. Earning and maintaining your trust is non-negotiable.
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