We provide independent regulatory, certification & operational support across healthcare, energy and industrial sectors — enabling safe market access, compliance, and system performance.
UK-based. Operating across the UK, EU, and international markets.
UKRP · EU-REP · EUDAMED
TIC · MDSAP · Second & Third-Party Auditing
MDR · IVDR · Machinery · Energy · ISO
CYB operates as a technical and regulatory delivery organisation, not a generalist consultancy.
We hold working knowledge of the regulatory frameworks, standards, and operational environments we service — built over more than three decades of direct engagement across the UK, EU-27, and international markets.
UKRP and EU-REP services for medical device and IVD manufacturers placing products on the UK and EU markets. Includes ongoing regulatory liaison, incident reporting, and post-market support.
Data entry, actor registration, device registration, UDI management, and submission tracking within the European database for medical devices. Available as a standalone service or integrated within a wider regulatory programme.
Testing, inspection, and certification activities covering machinery, pressure equipment, and product conformity. Third-party delivery structured around ISO 17020, 17025, and related standards.
Multi-standard audit programmes across ISO 9001, 13485, 14001, 45001, 50001, 27001, and sector-specific frameworks. Delivered on-site or remotely by experienced auditors with direct industry backgrounds.
End-to-end compliance support for medical device and in vitro diagnostic manufacturers across the EU Medical Device Regulation (2017/745) and IVDR (2017/746). Technical file review, clinical evidence assessment, and PMS support included.
ISO 50001 energy management, machinery and pressure equipment conformity, and operational systems support across industrial, manufacturing, and infrastructure environments.
Our approach is evidence-led, structured & designed for real-world application — not theory.
Support across UK and EU regulatory frameworks, including UKRP, EU-REP, MDR, IVDR, and EUDAMED.
Ensuring structured, compliant, and efficient pathways to market.
Planning, coordination, and execution of complex field and technical operations.
Supporting installations, supply chains, and operational environments end-to-end.
Independent auditing, testing, and certification activities.
Delivering objective oversight and audit-ready outcomes.
We don’t operate as traditional consultants.
We work alongside your teams — focused on delivery, not theory.
Identify the unique needs of your sector.
Develop tailored strategies to meet objectives.
Implement solutions and monitor progress.
Evaluate results and refine processes.
