A registered UK Responsible Person and EU Authorised Representative — not a consultancy, and not a reseller. We hold the registrations, we do the work, and we are accountable for the outcomes.
Cyberpan Support Services Ltd and UKALIA Ltd are UK-registered entities providing regulatory representation services for medical device and IVD manufacturers entering and operating in the UK and EU markets.
We were established in an era — and an operational context — where regulatory work meant being present in the field, inside the facility, and accountable to an authority. That background shapes how we work today: practically, accurately, and without unnecessary overheads.
UK Responsible Person (UKRP) services. MHRA registration and regulatory correspondence. Management system auditing and TIC services.
EU Authorised Representative (EC-REP) services. Registered in Belfast, Northern Ireland — providing access to EU markets via the NI Protocol.
Cyberpan Support Services Ltd is registered as a UK Responsible Person with the MHRA.
[Registration number to be inserted]
UKALIA Ltd is registered as an EU Authorised Representative. Registration held via Belfast, Northern Ireland under the NI Protocol.
Active EUDAMED actor registration. Device registration and UDI management available as part of EC-REP service or as standalone.
Regulatory and technical delivery operations established in the 1980s. UK-registered entities currently operating.
Professional indemnity and public liability insurance maintained. Details available on request.
CYB operates to an integrated management system aligned with the following international standards and frameworks:
Quality management standard focused on consistently delivering products/services that meet customer and regulatory requirements, while improving processes and customer satisfaction.
Quality management standard specifically for medical devices, covering design, manufacture, supply, installation, servicing, risk management, traceability, and regulatory compliance.
Environmental management standard that helps organisations manage environmental responsibilities, reduce environmental impact, meet compliance obligations, and improve sustainability performance.
Occupational health and safety management standard focused on preventing work-related injury and ill health, improving workplace safety, and managing health and safety risks.
Energy management standard that helps organisations improve energy performance, reduce energy use, lower costs, and support carbon reduction goals.
Information security management standard for protecting data through risk assessment, security controls, governance, and continual improvement of information security practices.
Standard for inspection bodies, setting requirements for competence, impartiality, consistency, and reliability when carrying out inspections.
Standard for testing and calibration laboratories, demonstrating technical competence, reliable results, valid methods, equipment control, and quality assurance.
Alessandro Gambara
Alessandro’s professional background was built in mission-critical environments from the 1980s onward — offshore operations, sterile manufacturing, seismic and drilling programmes, laboratory governance, and international certification delivery. He leads strategic direction and senior regulatory engagement across both entities.
His approach to regulatory work is direct: define the scope, execute the registration, manage the obligation. The client’s time to market is the measure of success, not the volume of documentation produced.
Offshore safety oversight & drilling operations
Decisions are owned. Scope, timelines, and deliverables are defined before work begins. Changes are communicated, not assumed.
Technical conclusions are based on evidence, not on what the client wants to hear. Audit and assurance work is independent.
All outputs are documented. Evidence is structured to support regulatory review, third-party audit, or internal management review.
Controls and recommendations are scaled to the actual risk and complexity of the situation, not over-engineered for the appearance of rigour.
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.
Full service delivery. Primary operating base. UKRP registration and UK market representation for medical devices and IVDs.
EU-REP services, EUDAMED management, MDR/IVDR compliance support, and audit delivery across European member states.
Regulatory characterisation, multi-jurisdictional certification, and TIC delivery for global manufacturers accessing multiple markets.
We’re dedicated to enhancing governance and compliance in healthcare and energy sectors. Let’s work together to navigate challenges and drive sustainable outcomes.
