ARC Regulatory
ARC Regulatory is a Belfast-based regulatory consultancy and CRO, founded in 2010, that helps medical device and IVD manufacturers achieve CE Marking compliance, with specialist expertise in EU AI Act and EU MDR 2017/745 requirements for AI-powered devices.
- Company typePrivate
- Founded2010
- HeadquartersBelfast, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What ARC Regulatory does
ARC Regulatory is a private, for-profit medical device consultancy and clinical research organisation (CRO) founded in 2010 and headquartered in Belfast, United Kingdom, with a reported headcount of 11-50 employees. The firm specialises in regulatory solutions for the in-vitro diagnostic (IVD) and medical device industries, with publicly visible expertise in helping manufacturers navigate the dual framework of the EU AI Act (Regulation 2024/1689) and EU MDR 2017/745 when seeking CE Marking for AI-powered medical devices.
Its service scope covers compliance dimensions specific to high-risk AI medical devices, including data governance, human oversight mechanisms, automated logging, and EU AI Database registration, with public commentary anchored to the 2 August 2027 compliance deadline. The firm's customer base is concentrated in the medical device manufacturer segment, addressed through a vertical go-to-market model.
ARC Regulatory's revenue model and pricing have not been disclosed, and its website currently resolves to a verification placeholder. No funding rounds, investor information, partnership agreements, named customer logos, M&A activity, leadership-team disclosures, or product catalogue details were present in the available data, leaving significant gaps in structural, commercial, and operating visibility.
ARC Regulatory firmographics
Firmographics- Name
- ARC Regulatory
- Website
- https://arc-regulatory.co.uk
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ARC Regulatory is a Belfast-based regulatory consultancy and CRO, founded in 2010, that helps medical device and IVD manufacturers achieve CE Marking compliance, with specialist expertise in EU AI Act and EU MDR 2017/745 requirements for AI-powered devices.
- Ownership category
- akta.pro rank
ARC Regulatory industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- akta.pro primary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
- akta.pro secondary industry
- Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN)
Keywords
Where ARC Regulatory is headquartered
LocationHeadquarters
- HQ city
- Belfast
- HQ country
- United Kingdom
- HQ region
- Europe
Markets served
ARC Regulatory business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales
ARC Regulatory product offering
Product offeringCore offering
ARC Regulatory is a medical device consultancy and clinical research organisation that provides regulatory affairs services to IVD and medical device manufacturers. Its work centres on preparing clients for CE Marking under EU MDR 2017/745 and on guiding AI-enabled medical devices through the EU AI Act (Regulation 2024/1689), including data governance, human oversight mechanisms, automated logging, and EU AI Database registration.
Product overview
No product or service information available for ARC Regulatory in the provided source data.
Differentiator
Problem solved
Functional benefit
Products and services
- Regulatory Affairs & Clinical Research Services
Companies that use ARC Regulatory
Customer profileSegments1 record
Ideal customer profiles1 record
ARC Regulatory technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
ARC Regulatory partnerships and signals
Strategic signalRecent moves3 records
Expansion highlights3 records
ARC Regulatory competitors and assessment
Company assessmentDirect peers
- RQM+: RQM+ is a regulatory and quality consulting firm focused exclusively on medical devices and IVDs, offering services spanning regulatory strategy, submissions, and quality systems. It is the closest direct peer to ARC Regulatory in terms of niche focus, customer base (medical device manufacturers), and service offering (CE/UKCA marking support).
- NAMSA: NAMSA is a medical device-focused CRO that combines regulatory consulting, biocompatibility testing, and clinical research services for medical device manufacturers. It is comparable to ARC Regulatory in serving the same buyer (medical device companies), offering both clinical and regulatory services, and emphasising pre-market pathway support.
- ProPharma Group: ProPharma Group provides regulatory affairs, compliance, and quality assurance consulting to the medical device and pharmaceutical industries. It is comparable to ARC Regulatory in its regulatory consulting focus and serving manufacturers seeking MDR/IVDR compliance support.
- Emergo by UL: Emergo by UL is a regulatory consultancy specialising in medical device and IVD market access, including CE/UKCA marking, FDA submissions, and quality systems. It is directly comparable to ARC Regulatory as a regulatory affairs specialist serving the same medical device manufacturer customer base.
Broad incumbents
- IQVIA: IQVIA is one of the world's largest CROs and offers regulatory affairs services to medical device and pharmaceutical manufacturers globally. It is comparable as a broad incumbent in the same regulatory consulting market, with significantly greater scale and global reach than ARC Regulatory.
- ICON plc: ICON plc is a global CRO providing clinical research and regulatory services to the medical device and biopharma industries. It competes in the same medical device regulatory and clinical research market as ARC Regulatory but at vastly greater scale and with broader geographic coverage.
- Charles River Laboratories: Charles River Laboratories provides CRO services, including regulatory affairs and medical device consulting, with a global footprint. It is comparable to ARC Regulatory in regulatory service offerings to medical device manufacturers, though its primary focus is broader life sciences research services.
- Medpace: Medpace is a global CRO offering clinical research and regulatory support to medical device and pharmaceutical manufacturers. While its primary focus is clinical trials, it competes for the same manufacturer customers and offers regulatory services relevant to ARC Regulatory's market.
Emerging players
- BSI Group: BSI Group is a notified body that certifies medical devices for CE marking and also offers regulatory consulting and standards-related services. It is comparable as it sits at the receiving end of the same CE marking pathway that ARC Regulatory's clients are preparing for, and increasingly offers adjacent consultancy services.
- TÜV SÜD: TÜV SÜD is a notified body providing medical device certification and testing services, alongside regulatory consulting offerings. It is comparable as it engages with the same MDR/IVDR framework and increasingly offers consultancy that overlaps with ARC Regulatory's services.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks6 records
Key highlights5 records
Customer concentration
ARC Regulatory social profiles
Digital presenceARC Regulatory financial estimates
Financial estimateRevenue estimate
Valuation estimate
ARC Regulatory leadership team
Management profileNumber of profiles
ARC Regulatory funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ARC Regulatory M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ARC Regulatory
What does ARC Regulatory do?
ARC Regulatory is a medical device consultancy and clinical research organisation that provides regulatory affairs services to IVD and medical device manufacturers. Its work centres on preparing clients for CE Marking under EU MDR 2017/745 and on guiding AI-enabled medical devices through the EU AI Act (Regulation 2024/1689), including data governance, human oversight mechanisms, automated logging, and EU AI Database registration.
Is ARC Regulatory a public or private company?
ARC Regulatory is a private company. It is classified as unknown and is currently operating.
When was ARC Regulatory founded?
ARC Regulatory was founded in 2010. It employs 11 to 50 people.
Where is ARC Regulatory based?
ARC Regulatory is headquartered in Belfast, United Kingdom, in the Europe region.
Who are ARC Regulatory's main competitors?
Direct peers on record are RQM+, NAMSA, ProPharma Group and Emergo by UL. Broad incumbents are IQVIA, ICON plc, Charles River Laboratories and Medpace. Emerging players are BSI Group and TÜV SÜD.
Does ARC Regulatory have an API?
No public API is recorded for ARC Regulatory.
What industry is ARC Regulatory in?
ARC Regulatory's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management), with a secondary code of HLACAOAN, Regulatory Submissions & Clinical Content Management (eCTD/Publishing).