Advena
Advena Limited is a UK-based regulatory affairs consultancy that helps medical device and cosmetics manufacturers achieve EU MDR, UKCA, IVDR, and ISO 13485 compliance through bespoke advisory services, training, and its proprietary ACTIV eQMS software.
- Company typePrivate
- Founded2001
- HeadquartersWarwick, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
Advena firmographics
Firmographics- Name
- Advena
- Legal name
- Advena Limited
- Website
- https://advenamedical.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Advena Limited is a UK-based regulatory affairs consultancy that helps medical device and cosmetics manufacturers achieve EU MDR, UKCA, IVDR, and ISO 13485 compliance through bespoke advisory services, training, and its proprietary ACTIV eQMS software.
- Ownership category
- akta.pro rank
Advena industry classification
Industry- Product category
- Regulatory Affairs Consulting
- SIC
- Services-Management Consulting Services (8742), Services-Computer Programming Services (7371)
- akta.pro primary industry
- Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)
- akta.pro secondary industry
- PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited) (HLAGALAJ)
Keywords
Where Advena is headquartered
LocationHeadquarters
- HQ city
- Warwick
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
Advena business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure, Supply Chain
Revenue model
- Regulatory Consultancy Services: Professional consultancy services for medical device regulatory compliance, quality management, and cosmetics regulation. Charged at hourly rates specified in quotations, with 50% deposit required for new clients prior to commencement of contracted works.
- Training Services: Bespoke training services for medical device regulations and quality management systems, delivered virtually or onsite.
- ACTIV eQMS Software: Electronic Quality Management System software subscription/licensing for managing QMS documentation and compliance.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Consultancy services - hourly rate based |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
Advena product offering
Product offeringCore offering
Advena provides regulatory affairs consulting services and a proprietary electronic Quality Management System (ACTIV eQMS) for medical device and cosmetics manufacturers. Its services cover EU MDR, UKCA, IVDR, and ISO 13485 compliance, UK/EU Responsible Person representation, PRRC outsourcing, auditing, training, and mentoring for SMEs. The ACTIV platform offers integrated modules for document control, audit management, risk management, and incident tracking in an ISO 13485:2016-compliant environment.
Product overview
Advena is a regulatory consultancy offering both proprietary software products and professional services. The core product is ACTIV, an electronic Quality Management System (eQMS) composed of 13 integrated modules (Audit Manager, Processes, File Manager, Improvement Log, Business Risk Manager, Legal Compliance Manager, Incident Log, Customer and Supplier Manager, HR Manager, Asset Manager, Teams, and Forums) designed for ISO 13485:2016 compliance. The professional services portfolio includes Medical Device Consultancy, UK and EU Responsible Person services, IVD Consultancy, PRRC services, Quality Management services, MDSAP auditing, Auditing Services, Training Services, and Cosmetic Product Responsible Person services. The company also offers a Mentoring Service for SMEs seeking to build internal regulatory capabilities. Together, these offerings provide a comprehensive regulatory compliance ecosystem for medical device and cosmetics manufacturers.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device Consultancy
Quantifiable outcome
- Zero non-conformities for third consecutive ISO 13485 audit
Companies that use Advena
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles4 records
Advena technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
Advena partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Advena Ltd (Malta)coreStrategic partnership with Advena Ltd in Malta for EU Authorised Representative Services. This enables support for manufacturers based outside the UK and European Union seeking to access these markets.
Scale indicators3 records
Recent moves1 record
Expansion highlights6 records
Advena competitors and assessment
Company assessmentDirect peers
- Qualio: Qualio provides cloud-based eQMS software for life sciences companies seeking ISO 13485 compliance — comparable product/market overlap with Advena's ACTIV eQMS for medical device manufacturers.
- Greenlight Guru: Greenlight Guru offers an eQMS platform purpose-built for medical device ISO 13485 and FDA QSR compliance — a direct competitor to Advena's ACTIV eQMS offering in the same SME medical device segment.
- RQM+: RQM+ is a medical device regulatory and quality consulting firm that also operates a SaaS eQMS platform (RQM+) — directly comparable to Advena's mix of consultancy services and ACTIV eQMS software.
Broad incumbents
- MasterControl: MasterControl is a larger, established eQMS and quality management platform serving medical device and life sciences manufacturers — a broader incumbent whose QMS offering overlaps with ACTIV and whose professional services overlap with Advena's consulting.
- TÜV SÜD: TÜV SÜD is a global testing, inspection, certification, and training body with deep medical device regulatory services — comparable to Advena's ISO 13485/QMS/MDR offerings but at much larger scale and geographic breadth.
- NAMSA: NAMSA is one of the largest medical device-focused CROs offering regulatory, quality, and testing services — overlaps with Advena's MDR/IVDR consulting, although NAMSA skews toward larger enterprise manufacturers.
- NSF (NSF Health Sciences): NSF provides regulatory affairs consulting, training, and certification services for medical devices and cosmetics — comparable in service mix and regulatory expertise to Advena, but at significantly greater scale and global footprint.
- BSI Group: BSI Group is a global standards, certification, and regulatory consulting body — comparable to Advena's ISO 13485 certification and regulatory affairs work; notably, BSI is also Advena's own certification body.
- DEKRA: DEKRA is a global testing, inspection and certification organization with medical device regulatory services — comparable to Advena's ISO 13485 certification and MDR compliance support at significantly greater scale.
Others
- Regulatory Affairs Professionals Society (RAPS): RAPS is the leading professional association for regulatory affairs in healthcare products — not a direct competitor, but thematically adjacent given Advena's regulatory training services and consultants' involvement with TOPRA/BSI committees.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Advena social profiles
Digital presenceAdvena compliance and trust
Trust signalCompliance1 record
Advena financial estimates
Financial estimateRevenue estimate
Valuation estimate
Advena leadership team
Management profileNumber of profiles
Profiles15 records
Advena subsidiaries and ownership
Company hierarchySubsidiaries1 record
Advena funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Advena 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 Advena
What does Advena do?
Advena provides regulatory affairs consulting services and a proprietary electronic Quality Management System (ACTIV eQMS) for medical device and cosmetics manufacturers. Its services cover EU MDR, UKCA, IVDR, and ISO 13485 compliance, UK/EU Responsible Person representation, PRRC outsourcing, auditing, training, and mentoring for SMEs. The ACTIV platform offers integrated modules for document control, audit management, risk management, and incident tracking in an ISO 13485:2016-compliant environment.
Is Advena a public or private company?
Advena is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Advena founded?
Advena was founded in 2001. It employs 11 to 50 people.
Where is Advena based?
Advena is headquartered in Warwick, United Kingdom, in the Europe region.
How does Advena make money?
Three revenue lines are on record. Regulatory Consultancy Services are the primary driver. The others are training Services and ACTIV eQMS Software.
Who are Advena's main competitors?
Direct peers on record are Qualio, Greenlight Guru and RQM+. Broad incumbents are MasterControl, TÜV SÜD, NAMSA, NSF (NSF Health Sciences), BSI Group and DEKRA. Regulatory Affairs Professionals Society (RAPS) is listed as an others.
Does Advena have an API?
No public API is recorded for Advena.
What industry is Advena in?
Advena's product category is Regulatory Affairs Consulting. Its primary akta.pro industry code is BPADANAJ, Health, Pharmaceuticals & Medical Devices Regulatory Cooperation, with a secondary code of HLAGALAJ, PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited). Its SIC code is 8742.