Mission, Context & Governance

What we exist to do, how we’re structured, and the values that govern our conduct.

What CYB exists to do

CYB exists to reduce regulatory uncertainty and improve system performance for organisations operating in regulated markets.

What this means

This means helping manufacturers access UK and EU markets compliantly, helping operators maintain certification without unnecessary overhead, and helping organisations build management systems that function under audit conditions — not just on paper.

Our Approach

The work is grounded in direct operational experience. Leadership has held senior responsibility inside the same environments we supports: offshore safety, clinical device oversight, sterile manufacturing, energy systems, machinery commissioning, and laboratory governance.

– Services are not advisory in the conventional sense. They are structured delivery activities with defined scope, traceable outputs, and accountable outcomes.

Alessandro Gambara

Leadership

Alessandro Gambara founded Cyberpan Support Services Ltd and Ukalia Ltd and operates both entities within the CYB group. 

His professional background was established in disciplined, mission-critical environments from the 1980s onwards, providing an evidence-based and systems-driven foundation that continues to shape how work is delivered today.

Senior responsibility across more than three decades has spanned:

Offshore safety oversight & drilling operations

Seismic & subsurface survey programmes
Manufacturing governance & production quality systems
Laboratory controls & calibration environments
Machinery / pressure equipment inspection & certification
International certification delivery & multi-jurisdictional audit programmes
Medical device regulatory affairs & EUDAMED operations
Digital systems, information security, and SaMD lifecycle evaluation

Following Brexit, capability expanded to include specialist regulatory support for medical device and IVD operators navigating the post-MDR and IVDR landscape, with structured delivery aligned to EUDAMED, UKRP, and EU-REP requirements.

Structure & Registration

Legal entities

Cyberpan Support Services Ltd

Delivers regulatory, audit, TIC, and management system services across all sectors.

Primary operating entity

Specialist entity for UKRP, EU-REP, EUDAMED, MDR and IVDR services.

Operates under CYB group

Both entities trade under the CYB brand following merger of operations.

Maintained regulatory registrations, insurance cover, and embedded information security and privacy controls within digital platforms.

Standards & Governance Alignment

Management system framework

CYB operates to an integrated management system aligned with the following international standards and frameworks:

ISO 9001

ISO 13485
ISO 14001
ISO 45001
ISO 50001
ISO 27001
ISO 17020
ISO 17025

What this means

Alignment with these frameworks is applied to internal operations and used as the baseline for client-facing audit and certification delivery. This means the organisation is audited and operates under the same disciplines it delivers to others.

Annex SL

Annex SL structure is used throughout to ensure coherence across management system elements — leadership, planning, support, operation, performance evaluation, and improvement are treated as a connected system, not isolated functions.

Values & Conduct

How decisions are made

1

Accountability

Decisions are owned. Scope, timelines, and deliverables are defined before work begins. Changes are communicated, not assumed.

2

Neutrality

Technical conclusions are based on evidence, not on what the client wants to hear. Audit and assurance work is independent.

3

Traceability

All outputs are documented. Evidence is structured to support regulatory review, third-party audit, or internal management review.

4

Proportionality

Controls and recommendations are scaled to the actual risk and complexity of the situation, not over-engineered for the appearance of rigour.

5

Confidentiality

Client information is handled under ISO 27001-aligned controls. Sensitive data is not shared, stored in uncontrolled systems, or used beyond the agreed scope of work.

Geographic Scope

CYB operates from UK-based entities with delivery reach across:

United Kingdom

Full service delivery. Primary operating base. UKRP registration and UK market representation for medical devices and IVDs.

EU-27

EU-REP services, EUDAMED management, MDR/IVDR compliance support, and audit delivery across European member states.

International

Regulatory characterisation, multi-jurisdictional certification, and TIC delivery for global manufacturers accessing multiple markets.

Join Our Mission for a Sustainable Future

We’re dedicated to enhancing governance and compliance in healthcare and energy sectors. Let’s work together to navigate challenges and drive sustainable outcomes.