Certifications & Regulatory Readiness
Achieve compliance. Secure certifications. Unlock market access.
How We Help

Certification Planning & Project Management
We scope your certification roadmap according to your business needs and break it into actionable steps, including ISO 27001, ISO 13485, ISO 27701, MDR/IVDR or DPF. From timelines and documentation to team alignment, we provide the structure you need to move forward with clarity and control.

Selection & Coordination of Notified Bodies
We identify and connect you with the most suitable notified bodies, certification authorities, or regulatory partners. We manage all communication, submissions, and logistics – minimizing delays, avoiding costly errors, and keeping your certification on track.

Gap Assessment & Standard Alignment
We assess your current processes against applicable regulations and frameworks – including ISO 27001, ISO 13485, ISO 27701, MDR/IVDR, NIS2, AI Act, GDPR, ePrivacy, HIPAA, DORA, CCPA/CPRA, SOC 2, and PCI DS – implement what’s missing, including policies, controls, documentation, and operational processes, so you meet every requirement.

Customer & Partner Compliance Enablement
We support your business in meeting the compliance expectations of enterprise clients and partners. By managing audit requests, evidence mapping, and certification support, we help you turn compliance reviews into opportunities for growth and stronger partnerships.
Why CEOs Work With Us
We turn regulatory requirements into business accelerators – so you can grow, scale, and win new markets.
Read our latest insights
From idea to certification: regulatory readiness for medical software
Bringing a medical software product to life is exciting. You start with an idea — maybe an AI tool to help radiologists detect lung nodules, or a digital platform that helps labs interpret diagnostic [...]


