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Service - UKRP
A legal requirement for medical device and IVD manufacturers based outside the United Kingdom who place products on the GB market.
The UKRP acts as the regulatory point of contact with the MHRA and holds defined obligations under UK MDR 2002 and associated regulations.
Non-UK manufacturers of medical devices, IVDs, and combination products who wish to place, or continue placing, products on the Great Britain market following Brexit.
Features - UKRP
Outcome - UKRP
Named UKRP registration with the MHRA, structured reporting schedule, and access to regulatory liaison support throughout the engagement period. All correspondence managed and documented.
Available as standalone or within a wider UK/EU market access programme.
UK/EU Market Access - UKRP
A legal requirement for medical device and IVD manufacturers based outside the United Kingdom who place products on the GB market.
The UKRP acts as the regulatory point of contact with the MHRA and holds defined obligations under UK MDR 2002 and associated regulations.
UKRP and EU-REP services for medical device and IVD manufacturers placing products on the UK and EU markets.
Testing, inspection, and certification activities covering machinery, pressure equipment, and product conformity.
UK/EU Market Access - EU-REP
A mandatory appointment under EU MDR (2017/745) and IVDR (2017/746) for manufacturers based outside the European Union who place medical devices or IVDs on the EU market.
The EU-REP carries defined legal liability and is responsible for regulatory co-operation with competent authorities across member states.
Non-EU manufacturers — including UK manufacturers post-Brexit — who hold CE-marked products or are seeking CE marking under the current MDR/IVDR framework.
Formal EU-REP appointment documentation, registration confirmation, and a structured communication and reporting process aligned to your device risk class and regulatory timeline.
UK/EU Market Access - EUDAMED
EUDAMED is the European Commission’s central database for medical devices. Actors and devices must be registered within mandatory timelines.
Active management is required — data entries must be maintained, updated, and aligned with submission requirements across device modules.
Manufacturers, EU Representatives, Authorised Representatives, and Importers operating under EU MDR or IVDR who need structured, accurate, and up-to-date EUDAMED records.
Verified EUDAMED actor registration, structured device records, a maintained data schedule, and a traceable log of all submissions and updates.
Healthcare Compliance - MDR & IVDR
End-to-end compliance support for medical device and in vitro diagnostic manufacturers navigating the requirements of EU MDR (2017/745) and IVDR (2017/746).
This covers technical documentation, clinical evidence, post-market systems, and Notified Body engagement — delivered by people with direct experience of submission outcomes.
Device manufacturers preparing for initial CE marking, legacy device transition, IVDR reclassification, or ongoing compliance maintenance under the MDR/IVDR framework.
Structured compliance documentation, gap analysis reports, submission-ready technical files, and a clear compliance roadmap with defined milestones. All outputs are version-controlled and audit-ready.
Certification & Inspection - TIC
Third-party testing, inspection, and certification activities for products, plant, and processes.
Delivered against relevant harmonised standards, UK and EU conformity frameworks, and sector-specific technical requirements.
Manufacturers, operators, and contractors requiring independent inspection or certification for machinery, pressure equipment, lifting equipment, electrical systems, or process conformity — for market access, insurance, or regulatory purposes.
Audit - MDSAP
MDSAP allows a single regulatory audit to satisfy the requirements of five participating health authorities: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States (FDA).
A successful MDSAP audit eliminates the need for multiple separate regulatory audits across these jurisdictions.
Medical device manufacturers seeking market access in multiple MDSAP jurisdictions, particularly those targeting the Canadian market where MDSAP is mandatory, or those seeking to streamline multi-market regulatory programmes.
Audit - 2nd + 3rd Party
Independent audit services delivered against ISO management system standards and sector-specific frameworks.
ISO 9001
A formal audit report with classified findings, referenced evidence, and recommended actions. All reports are structured to support management review and regulatory inspection readiness.
Energy & Industrial - Energy Performance + ISO 50001
Structured energy management and performance improvement services for industrial, commercial, and infrastructure operators.
Aligned with ISO 50001:2018 (Energy Management Systems) and UK and EU sustainability reporting obligations.
Manufacturers, facilities operators, and commercial organisations with significant energy consumption, environmental reporting obligations, or sustainability performance targets.
Information Security + ISO 27001
Information security and privacy support for organisations handling sensitive commercial, clinical, or regulatory data.
Delivered in alignment with ISO 27001:2022 and the UK GDPR / EU GDPR framework.
Manufacturers, facilities operators, and commercial organisations with significant energy consumption, environmental reporting obligations, or sustainability performance targets.
This service is available as standalone or embedded within a wider management system programme for organisations seeking multi-standard certification.
Service - EU-REP
A mandatory appointment under EU MDR (2017/745) and IVDR (2017/746) for manufacturers based outside the European Union who place medical devices or IVDs on the EU market.
The EU-REP carries defined legal liability and is responsible for regulatory co-operation with competent authorities across member states.
Non-EU manufacturers — including UK manufacturers post-Brexit — who hold CE-marked products or are seeking CE marking under the current MDR/IVDR framework.
Features - EU-REP
Outcome - EU-REP
Formal EU-REP appointment documentation, registration confirmation, and a structured communication and reporting process aligned to your device risk class and regulatory timeline.
Available as standalone or within a wider UK/EU market access programme.
Service - EUDAMED
EUDAMED is the European Commission’s central database for medical devices. Actors and devices must be registered within mandatory timelines.
Active management is required — data entries must be maintained, updated, and aligned with submission requirements across device modules.
Manufacturers, EU Representatives, Authorised Representatives, and Importers operating under EU MDR or IVDR who need structured, accurate, and up-to-date EUDAMED records.
Features - EUDAMED
Outcome - EUDAMED
Verified EUDAMED actor registration, structured device records, a maintained data schedule, and a traceable log of all submissions and updates.
Service - MDR & IVDR
End-to-end compliance support for medical device and in vitro diagnostic manufacturers navigating the requirements of EU MDR (2017/745) and IVDR (2017/746).
This covers technical documentation, clinical evidence, post-market systems, and Notified Body engagement — delivered by people with direct experience of submission outcomes.
Device manufacturers preparing for initial CE marking, legacy device transition, IVDR reclassification, or ongoing compliance maintenance under the MDR/IVDR framework.
Features - MDR & IVDR
Outcome - EMDR & IVDR
Structured compliance documentation, gap analysis reports, submission-ready technical files, and a clear compliance roadmap with defined milestones. All outputs are version-controlled and audit-ready.
We provide a wide range of services focusing on healthcare compliance, energy performance, and risk management. Our expertise covers strategic support, training, and ensuring sustainability within mandated regulations. Let us help you navigate these complexities with ease.
You can reach us through the contact form on our website, or feel free to email us directly. We’re committed to responding swiftly to your inquiries. Don’t hesitate to connect with us to discuss how we can assist you.
We specialize in serving clients within the healthcare and energy sectors. Our understanding of governance and compliance challenges allows us to tailor solutions specifically for these dynamic industries.
Our approach involves close monitoring of regulatory changes, continuous training, and implementing proactive strategies. We also conduct regular assessments to ensure that your organization remains compliant with the latest standards and regulations.
Pricing can vary based on the specific services you need. We recommend reaching out for a tailored quote. Our goal is to provide value-driven solutions that meet your unique business needs.
Yes, we offer various training programs tailored to the needs of your staff. These programs cover compliance, risk management, and other critical areas relevant to your business, ensuring your team is well-prepared and knowledgeable.
