Full support for CyberSecurity sections in Regulatory Submissions, from initial classification to post-market surveillance. Includes Pre/Post CyberSecurity Documentation, Secure Product Development Frameworks, SBOM and Life Cycle Management, Incident and Breach Management, CSMP, post-market vulnerability response, etc.

Scoping, Implementation, Certification, and Maintenance of your ISO 27001 Information Security Management System, tailored for start-ups, SMEs, new ventures, and scale-ups. Includes process and documentation framework, certification roadmapping and support, internal audit and pre-certification, integration, authoring of policies, etc.

For international-facing organisations or those targeting the US market, Qity offers a full alignment service with NIST CSF, including mapping of existing controls to CSF functions, risk profiling, gap analysis against organisational tiers, etc.

Registration, Preparation, Roadmapping, and Implementation of processes, procedures, policies, and records to ensure compliance with the NIS2 Directive.

Such as Dora, FDA Guidelines, SOC 1 & 2, and others.

Independent and expert Audit Management against legal requirements, applicable standards, or regulatory environments.

Comprehensive Threat Modelling workshops and documentation services, tailored to healthcare and medical device industries, and including always up to date threat and attack vectors, using frameworks such as STRIDE and MITRE, and aligned with our Security Risk Management and Information Security Documentation (SOPs, Policies, and Work Instructions).

Development, Integration, and Execution of product-centric and/or organisation-centric Security Risk Management, supporting either a product or device file, or a starting point for the implementation of risk based frameworks and standard compliance (such as 27k or 80001).

By leveraging state-of-the-art processes, frameworks, and tools, scope and implement process and software solutions to vulnerability management, including monitoring, alarmistics, security incident, and breach management.

Black/Grey/White box testing, focused API testing, network testing, product testing, social engineering, and organisational challenge testing (including phishing gamification).