ITMedTech
Certify Faster. Operate Smarter.
We are a consulting company specializing in the IT, cybersecurity, privacy, medical devices, and artificial intelligence (AI) sectors. We provide services for defining, certifying, and operating management systems.
Services
Defining Management Systems
We help you design and implement tailored management systems that align with industry standards and best practices, ensuring your organization is structured for success.
Certification Support
Our experts guide you through the certification process, providing the tools and knowledge needed to achieve compliance with ISO and regulatory standards efficiently.
Operating Management Systems
We offer ongoing support to lead, manage, monitor, and improve your management systems, ensuring they remain effective and drive continuous improvement.
Domains
Cybersecurity
In cybersecurity, we focus on helping your organization ensure the security and privacy of information and assets critical to your business operations. We assist in defining and managing an Information Security Management System to implement both technical and organizational measures, while fostering a strong security culture within your organization.
Artificial Intelligence
In artificial intelligence (AI), we focus on helping you develop and rapidly deploy AI/machine learning (ML) solutions that comply with national regulations, such as the EU’s AI Act. We assist in defining an Artificial Intelligence Management System to address all stages of the AI Total Product Lifecycle, as expected by regulators in both the EU and US markets.
Medical Devices
In medical devices (MD), we assist in defining a Quality Management System required for MD manufacturers or key suppliers. We help you manage the medical device Product Lifecycle (PLC) for Software as a Medical Device (SaMD) products, enabling your organization to efficiently launch each product version in compliance with national market requirements.
Management Systems
ISO/IEC 27001:2022
Information security, cybersecurity and privacy protection — Information security management systems — Requirements.
ISO/IEC 27701:2019
Security techniques — Extension to ISO/IEC 27001 and ISO/IEC 27002 for privacy information management — Requirements and guidelines
ISO/IEC 27017:2015
Information technology — Security techniques — Code of practice for information security controls based on ISO/IEC 27002 for cloud services
ISO/IEC 42001:2023
Information technology — Artificial intelligence — Management system
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
21 CFR 820
Title 21 Food and Drugs Chapter I -Food and Drug Administration Department of Health and Human Services Subchapter H – Medical Devices Part 820 Quality System Regulation
Schedule a Meeting
We will reach out to you to arrange a free meeting at your convenience. This session will help us understand your needs and develop a tailored solution for you.