Compliance

Build and maintain an ISO 13485 quality management system for medical devices

Plan regulatory strategy, submissions and pathways for medical device launches

Run ISO 14971 medical device risk analysis, risk controls and post-market review

Design security controls and map them to SOC 2, ISO 27001, GDPR and HIPAA

Run an EU AI Act readiness check on an AI system before EU deployment

Run an ISO 42001 AI management system internal audit with forcing questions

Run medical device CAPA investigations with root cause analysis and effectiveness checks

Build security programs, SOC 2 and ISO 27001 roadmaps and board security reports

Review plans that touch customer data, compliance or production access for risk

Map control overlap across 12 compliance frameworks and consolidate audit evidence

Pressure-test a compliance program before a new framework or certification audit

Classify an AI system under EU AI Act risk tiers and list what follows

Guide 510(k), PMA and De Novo submissions and QMSR compliance for device makers

Prepare for an FDA 21 CFR 820 QMSR audit or Form 483 inspection

Prepare for GDPR internal reviews, breach audits and DPA investigations

Scan code for privacy risks, draft DPIAs and track data subject requests under GDPR

Build an ISO 27001 ISMS with risk assessments and controls for health tech firms

Verify ISO 27001 controls, write SoA and gap analyses before certification

Prepare for ISO 13485 QMS audits covering design controls, CAPA and post-market

Prepare an ISO 27001 ISMS internal audit or certification stage 1 review

Run ISO 42001 AI management system gap analysis, risk register and internal audit

Handle EU MDR classification, technical files, clinical evaluation and PSURs

Plan and run ISO 13485 internal audits and classify nonconformities for devices

Manage medical device document control, version changes and 21 CFR Part 11 signatures

Lead management reviews and quality governance as a medical device QMR

Design and maintain an ISO 13485 quality system with audits and CAPA support

Index of 15 regulatory and quality skills for ISO 13485, MDR, FDA and GDPR

Prepare FDA 510(k), De Novo and PMA packages and draft CE marking documentation

Run ISO 14971 medical device risk analysis, FMEA and risk controls

Get a SOC 2 Type II audit ready across the observation period

Map SOC 2 criteria, build control matrices and collect audit evidence

Draft a privacy policy covering data types, GDPR and clauses needing legal review

Assess Google Cloud workloads against sovereign data boundary and compliance frameworks

Author custom cloud controls and frameworks for Assured Workloads data boundaries

Map compliance requirements to Assured Workloads frameworks and cloud controls

Process GDPR data access requests by locating subject data and drafting a report

Draft security questionnaire answers from a vetted library in the vendor format

Map controls to SOC 2, GDPR, HIPAA and PCI-DSS requirements

Run a six step security and compliance checklist for deploying AI tools in China

Draft a compliance or privacy policy with a checklist, not legal advice

Check Android apps against Google Play policy and data disclosure requirements

Keep an EU AI Act inventory of each AI system with its role and risk tier

Draft an AI impact assessment with risk analysis and regulatory classification

Draft board and committee meeting minutes in your house format from the agenda

Track open NPRM comment periods and log whether to file a comment

Draft responses to data subject access, deletion and correction requests

Track entity filing deadlines by jurisdiction and flag what is due in 30 to 90 days

Start international hiring plans with EOR versus entity framing and a tracker

Update an international expansion tracker and surface unblocked and overdue tasks