Results for “medical-device”

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.

Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.

Integrates endpoint health signals from CrowdStrike ZTA, Microsoft Intune, and Jamf into conditional access policies to enforce device compliance before granting resource access.

Acquire and analyze mobile device data using Cellebrite UFED and open-source tools to extract communications, location data, and application artifacts.

Restricts unauthorized removable media access on endpoints by implementing USB device control policies via Group Policy, Intune, or EDR platforms to prevent data exfiltration and malware introduction.

Drafts a Bring Your Own Device (BYOD) policy for U.S. employers governing personal device access to company systems. Covers MDM enrollment, encryption, remote wipe authority, privacy expectations, data classification, and regulatory overlays (HIPAA, GLBA, SOX, GDPR). Use when creating or updating BYOD policies, mobile device security policies, or personal device programs.

Performs comprehensive security assessments of IoT devices and their ecosystems by testing hardware interfaces, firmware, network communications, cloud APIs, and companion mobile applications.

Prepares for FDA QSR audits by asking six forcing questions covering complaints, process validation, DHRs, CAPAs, labeling, and Form 483 history.