AdviQual
AdviQual is a privately held Istanbul-based regulatory and quality management consulting firm serving medical device and IVD manufacturers. It provides CE certification, QMS, clinical documentation, validation, and training services across the product lifecycle, coordinated with group companies DeSia and NioReg.
- Company typePrivate
- Founded-
- HeadquartersIstanbul, Türkiye
- Headcount1–10
- GTM typeB2B
- OfferingServices
What AdviQual does
AdviQual Endüstriyel Danışmanlık Sanayi ve Ticaret Limited Şirketi is a privately held Turkish consulting firm founded in 2015 and headquartered in the Bahçeşehir district of Başakşehir, Istanbul. The firm provides regulatory and quality management consulting services to medical device and in vitro diagnostic (IVD) device manufacturers, with a service portfolio spanning licensing and quality management strategy, clinical documentation, clinical investigations, biocompatibility assessment (ISO 10993), usability engineering (IEC 62366-1), validation (process, method, sterilization per ISO 11135, and transport simulation per ASTM D4169), software validation (IEC 62304, ISO 80002), accredited test coordination, and structured training programs covering EU MDR 2017/745, IVDR 2017/746, ISO 13485:2016, and ISO 14971.
The firm's operational model is differentiated by an integrated ecosystem of group companies: DeSia Clinical handles clinical investigations and Post-Market Clinical Follow-up (PMCF), while NioReg provides validation and accredited testing services. This structure allows AdviQual to offer manufacturers a single coordination point across the regulatory, technical, clinical, validation, and testing workstreams required for CE certification, ÜTS registration, and post-market compliance. The team of approximately nine senior consultants and project managers holds advanced degrees from Turkish, German, and US institutions and has managed approvals with multiple Notified Bodies and Authorized Authorities.
Commercially, AdviQual operates on a project-based and retainer professional services model with quote-based pricing for consulting engagements, supplemented by tiered public training programs (early-bird and standard pricing with multi-participant discounts) and per-session mentorship offerings. Customer acquisition is driven by direct B2B sales, industry trade fair participation (MEDICA, Expomed Eurasia), and referral networks, with documented client engagements spanning established manufacturers such as Doğsan (surgical sutures), İnosens (VR-based physiotherapy software), and start-ups such as Interact Technologies (rehabilitation robotics). The firm has also extended its communication network into Japan, India, and the United States through international partnerships initiated at MEDICA.
AdviQual firmographics
Firmographics- Name
- AdviQual
- Legal name
- AdviQual Endüstriyel Danışmanlık Sanayi ve Ticaret Limited Şirketi
- Website
- https://adviqual.com.tr
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- AdviQual is a privately held Istanbul-based regulatory and quality management consulting firm serving medical device and IVD manufacturers. It provides CE certification, QMS, clinical documentation, validation, and training services across the product lifecycle, coordinated with group companies DeSia and NioReg.
- Ownership category
- akta.pro rank
AdviQual industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Scientific Research and Development Services (5417)
- akta.pro primary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
- akta.pro secondary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
Keywords
Where AdviQual is headquartered
LocationHeadquarters
- HQ city
- Istanbul
- HQ country
- Türkiye
- HQ region
- Europe
Offices1 record
Markets served
AdviQual business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Regulatory and Quality Consulting Services: AdviQual generates revenue through professional consulting engagements covering regulatory strategy, technical file preparation, clinical documentation, QMS implementation, risk management, validation, usability, software validation, and biocompatibility assessment. Services are offered to medical device and IVD manufacturers, typically on a project or retainer basis. Pricing is quote-based and varies by scope, complexity, and client size.
- Training and Seminar Programs: Revenue is also generated from training programs on regulatory topics (MDR, IVDR, ISO 13485, ISO 14971, etc.), offered as both public courses and in-house/firm-specific sessions. Training formats range from half-day seminars to 2-day intensive courses, with early-bird and standard pricing tiers. Additional services include mentorship and advisory sessions billed by session duration.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | One-time | Public Training - Early Bird (KVD & PMCF) |
| Unit Pricing | One-time | Public Training - Standard Rate (KVD & PMCF) |
| Unit Pricing | Per session | Mentorship / Advisory Sessions |
| Other | Multi-year contract | Consulting Services (Regulatory, QMS, Clinical, Validation) |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels6 records
AdviQual product offering
Product offeringCore offering
AdviQual is a B2B consulting firm providing regulatory strategy, quality management system (QMS) implementation, clinical documentation, validation, and training services to medical device and in vitro diagnostic device manufacturers. The firm guides manufacturers through EU MDR 2017/745 and IVDR 2017/746 compliance, technical file preparation, clinical evaluation, and CE certification, coordinating with group companies DeSia (clinical research) and NioReg (accredited testing) to deliver end-to-end regulatory solutions.
Product overview
AdviQual is a consulting firm offering a comprehensive portfolio of regulatory and quality management services for medical device and in vitro diagnostic device manufacturers. The core offering consists of consulting services including Licensing and Quality Management Consulting, Clinical Documentation, Clinical Investigations, Biocompatibility Assessment, Usability, Validation, Software Validation, Test Services, Training, Product Liability Insurance support, and Proposal Documentation. These services are designed to guide manufacturers through the entire product lifecycle—from regulatory strategy and technical file preparation through clinical evaluation, validation, and post-market surveillance. The company also provides training programs covering EU MDR 2017/745, EU IVDR 2017/746, ISO 13485:2016, ISO 14971 risk management, usability, software validation, root cause analysis, change management, design process control, and transport simulation validation. Group companies DeSia (clinical research) and NioReg (validation and testing) provide supplementary specialized services.
Differentiator
Problem solved
Functional benefit
Products and services
- Ruhsatlandırma ve Kalite Yönetimi Danışmanlığı (Licensing and Quality Management Consulting) Strategic regulatory and quality management consulting for medical device manufacturers, covering compliance with EU MDR 2017/745, ISO 13485, MDSAP, and other regulations. Includes QMS setup, CE certification support, and Notified Body audit preparation.
- Klinik Dokümantasyon (Clinical Documentation) Clinical documentation services including clinical evaluation reports (CER), post-market surveillance (PMS) documentation, and post-market clinical follow-up (PMCF) activities aligned with MDR requirements.
- Klinik Araştırmalar (Clinical Investigations) Clinical investigation planning and consultancy services for medical devices, supported by group company DeSia Clinical. Covers clinical study design, protocol development, and clinical evidence generation.
- Biyouyumluluk Değerlendirmesi (Biocompatibility Assessment) Biocompatibility documentation and assessment services in accordance with ISO 10993 standards for biological evaluation of medical devices.
- Kullanılabilirlik (Usability Engineering) Usability engineering services according to IEC 62366-1:2015, covering user profile definition, use environment analysis, and usability test design for medical devices.
- Validasyon (Validation Services) Process, method, and sterilization validation services, including EO sterilization validation (ISO 11135) and transport simulation validation (ASTM D4169).
- Yazılım Validasyonu (Software Validation) Software validation services covering both off-the-shelf software (ISO 80002) and custom software development (IEC 62304), including Agile project management methodologies.
- Test Hizmetleri (Test Services) Facilitation and coordination of accredited testing services including electrical safety, biocompatibility, EMC, and transport simulation testing in partnership with NioReg.
- Eğitimler (Training Programs) Comprehensive training programs covering EU MDR 2017/745, EU IVDR 2017/746, ISO 13485, ISO 14971 risk management, usability engineering, software validation, and root cause analysis. Offered as public courses and in-house/firm-specific sessions.
- Ürün Sorumluluk Sigortası (Product Liability Insurance Support) Professional guidance and partnership facilitation for obtaining product liability insurance solutions for medical device manufacturers.
- Teklif Dokümantasyonu (Proposal Documentation) Preparation of tender and proposal documentation for medical device regulatory and quality management services.
- Mentörlük - Danışmanlık (Mentorship and Advisory Sessions) Structured interactive online consultation sessions offered in 1-hour, 3-hour, and 5-hour formats for associations, clusters, universities, and start-up companies covering regulatory, clinical, biological, toxicological, quality, validation, usability, testing, factory setup, accreditation, and clinical investigation topics.
Quantifiable outcome
- CE certification obtained for AssistOn-Arm upper extremity exoskeleton robot (Interact Technologies)
- +2 more outcomes
Companies that use AdviQual
Customer profileNamed customers4 records
Ideal customer profiles3 records
AdviQual technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
AdviQual partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered supporting and core.
- T.C. Sağlık Bakanlığı - Türkiye İlaç ve Tıbbi Cihaz Kurumu (Turkish Medicines and Medical Devices Institution)supportingAdviQual's founder Başak Baranoğlu served as session chair and moderator for Session VIII: Medical Device Regulation - EU MDR 2017/745 at the International Product Safety Symposium organized under the AB and Turkey co-financed Technical Support Project. Representatives from the institution participated as speakers, and AdviQual's collaboration with the institution's Onaylanmış Kuruluş ve Klinik Araştırmalar Daire Başkanlığı (Notified Body and Clinical Investigations Department) was referenced in company materials.
- Eurofins (Biological Evaluation)supportingEurofins is a strategic solutions partner contributing to AdviQual's biological evaluation training and seminars. On February 25, 2021, Eurofins collaborated with AdviQual to deliver a free seminar on 'Biological Evaluation for Medical Devices' (Tıbbi Cihazlar için Biyolojik Değerlendirme) via ZOOM, presented by Paolo Pescio, covering ISO 10993 standard series, biological evaluation concepts, and case studies within the global regulatory framework.
- DeSia (DeSia Clinical)coreDeSia is a group company specializing in clinical research and Post-Market Clinical Follow-up (PMCF) activities. AdviQual leverages DeSia's clinical expertise to provide integrated clinical investigation planning, clinical data evaluation, and related services as part of its comprehensive regulatory compliance ecosystem. Together, the two companies offer a one-coordination solution covering all technical, clinical, validation, and testing processes for medical device manufacturers.
- NioRegcoreNioReg is a group company providing validation and accredited testing services, including ASTM D4169 transport simulation testing. AdviQual coordinates with NioReg to deliver validation services, test coordination, and accredited testing solutions as part of its integrated regulatory service offering, enabling manufacturers to access comprehensive testing through a single coordination point.
- ÇASGEM and TÜMDEF (Turkey)supportingAdviQual collaborated with ÇASGEM (Çalışma ve Sosyal Güvenlik Eğitim ve Araştırma Merkezi) and TÜMDEF (Tıbbi Ürünler ve Kalite Derneği) to deliver sector information training sessions on EU 2017/745 MDR (Medical Device Regulation) in Ankara, Istanbul, and Izmir, expanding regulatory awareness among Turkish medical device manufacturers.
- International Business Partners (Japan, India, USA)supportingAt MEDICA trade fair, AdviQual expanded its communication network and established agreements with business partners in Japan, India, and the United States to share mutual projects. These partnerships support AdviQual's international expansion and cross-border regulatory consulting for medical device manufacturers targeting global markets.
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
AdviQual competitors and assessment
Company assessmentBroad incumbents
- TÜV Rheinland: TÜV Rheinland is a major international Notified Body and testing/certification provider with extensive medical device services. Comparable to TÜV SÜD, it operates both as a regulator-side partner and a broad-service incumbent potentially competing with AdviQual on consulting and testing engagements.
- BSI Group: BSI is a UK-headquartered standards body and major EU Notified Body for medical devices and IVDs. Frequently the recipient of technical files prepared by consultancies like AdviQual, BSI also offers a wider range of certification, training, and assessment services that overlap with the compliance and QMS support AdviQual provides.
- ICON plc: ICON plc is a leading global CRO providing clinical research, regulatory, and laboratory services across pharma and medical devices. Represents the large-scale, broad-portfolio end of the spectrum against which AdviQual's boutique clinical/regulatory offering competes—particularly for medical device sponsors seeking full-service CRO partners.
- IQVIA: IQVIA is the world's largest CRO and a major provider of regulatory and quality services for medical device manufacturers globally. Its scale and breadth represent the upper bound of competition that small specialty consultancies like AdviQual face, especially on multi-region device programs.
- DEKRA: DEKRA is a global testing, inspection, and certification organization with a significant medical device practice (product safety testing, certification, audits). Overlaps with AdviQual/NioReg on accredited testing services and QMS/regulatory audit support.
- TÜV SÜD: TÜV SÜD is a global Notified Body and testing/certification organization with deep medical device practice (MDR/IVDR, ISO 13485, IEC 60601). Often serves as the Notified Body for submissions that firms like AdviQual prepare, and also offers adjacent consulting/testing—placing it as both a partner and a broad incumbent competitor to AdviQual's services.
Direct peers
- NAMSA: NAMSA is one of the largest independent medical-device-focused contract research and consulting organizations, offering regulatory, clinical, and laboratory testing services to medical device manufacturers worldwide. Highly comparable to AdviQual's MDR/IVDR regulatory, clinical investigation, biocompatibility, and validation offering, but at significantly greater scale and global reach.
- Medidee Services: Medidee is a Switzerland-based regulatory, clinical, and quality consulting firm dedicated to medical devices and IVDs under MDR/IVDR. Closest European mid-size peer to AdviQual in terms of service mix (regulatory strategy, clinical evaluation, QMS, software/biocompatibility), and a likely direct competitor for cross-border European engagements.
- RQM+: RQM+ is a U.S.-headquartered regulatory and quality consulting firm specializing in medical device and IVD compliance (FDA, EU MDR/IVDR, ISO 13485). Provides technical file/510(k), QMS, and clinical evaluation services that directly overlap with AdviQual's core consulting portfolio, with comparable specialty-device focus.
- Eurofins Medical Device Services: Eurofins is a global laboratory testing group with a dedicated medical device services division (biocompatibility, microbiology, packaging). Eurofins is a confirmed AdviQual seminar/training partner for biological evaluation and is functionally comparable for biocompatibility/ISO 10993 work AdviQual coordinates via NioReg.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
AdviQual social profiles
Digital presenceAdviQual compliance and trust
Trust signalCompliance1 record
AdviQual financial estimates
Financial estimateRevenue estimate
Valuation estimate
AdviQual leadership team
Management profileNumber of profiles
Profiles8 records
AdviQual subsidiaries and ownership
Company hierarchySubsidiaries2 records
AdviQual funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AdviQual 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 AdviQual
What does AdviQual do?
AdviQual is a B2B consulting firm providing regulatory strategy, quality management system (QMS) implementation, clinical documentation, validation, and training services to medical device and in vitro diagnostic device manufacturers. The firm guides manufacturers through EU MDR 2017/745 and IVDR 2017/746 compliance, technical file preparation, clinical evaluation, and CE certification, coordinating with group companies DeSia (clinical research) and NioReg (accredited testing) to deliver end-to-end regulatory solutions.
Is AdviQual a public or private company?
AdviQual is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was AdviQual founded?
AdviQual was founded in -1. It employs 1 to 10 people.
Where is AdviQual based?
AdviQual is headquartered in Istanbul, Türkiye, in the Europe region.
How does AdviQual make money?
Two revenue lines are on record. Regulatory and Quality Consulting Services are the primary driver. The others are training and Seminar Programs.
Who are AdviQual's main competitors?
Broad incumbents on record are TÜV Rheinland, BSI Group, ICON plc, IQVIA, DEKRA and TÜV SÜD. Direct peers are NAMSA, Medidee Services, RQM+ and Eurofins Medical Device Services.
Does AdviQual have an API?
No public API is recorded for AdviQual.
What industry is AdviQual in?
AdviQual's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight), with a secondary code of HLAGAAAA, Clinical CROs (Phase I–IV). Its NAICS code is 5417.