We provide independent regulatory, certification & operational support across healthcare, energy and industrial sectors — enabling safe market access, compliance, and system performance.
Field services, installations, technical operations, and supply chain support
Independent assurance, auditing, and certification pathways
Healthcare, energy, industrial, construction, and regulated environments
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.
Ongoing regulatory liason
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.
Multi-standard audit programmes 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).
Across industrial, manufacturing, and infrastructure environments.
Our approach is evidence-led, structured & designed for real-world application — not theory.
Medical device manufacturers, IVD producers, pharmaceutical groups, NHS and private healthcare providers, sterile processing and laboratory environments.
Complex manufacturers, precision engineering, calibration and testing facilities, production and QC environments, logistics and warehousing operations.
Offshore and subsurface operators, mechanical and electrical systems, pressure equipment environments, energy management and efficiency programmes.
Contractors and principal designers with machinery conformity, pressure testing, and occupational health and safety obligations.
Law firms, professional services organisations, and regulated advisors requiring information security, ISO 27001 support, or third-party audit services.
Businesses across sectors needing management system certification support, supplier auditing, or regulatory compliance frameworks without in-house capability.
Leadership has worked inside the environments it now advises on — offshore operations, sterile manufacturing, machinery commissioning, regulatory submissions, and clinical settings. This is not theoretical.
Services are structured as a connected system. UKRP representation links to EUDAMED management links to post-market surveillance links to audit. Each service reinforces the next.
Pricing is transparent, scope is defined upfront, and engagements are sized appropriately. Fixed fees and retainer structures are available as alternatives to open-ended day-rate arrangements.
Contact us to describe your situation. We will confirm scope, timeline, and cost before any engagement begins.
