UDEM

What UDEM does

UDEM A.Ş. (legal name: UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi Sanayi ve Ticaret Anonim Şirketi) is a Turkey-headquartered conformity assessment and certification body founded in 2005 in Ankara. The company operates as an EU Notified Body (designation 2292) under (AB) 2017/745 Medical Device Regulation (MDR), 2006/42/EC Machinery Directive, and 2014/33/EU Elevator Directive, and holds TÜRKAK accreditation for its LVD testing laboratory under TS EN ISO 17025 and for ISO 13485:2016 medical device quality management system certification. Service offerings include CE product certification, ISO 13485 system certification, MDR conformity assessment (including MDR Article 117 Notified Body Opinion for drug-device combination products), LVD testing, machine safety and elevator certification, construction products certification under 305/2011/EU, and adjunct training courses on medical device software validation and product certification. A TÜRKAK-accredited in-house laboratory provides insulation, leakage, high voltage, grounding, temperature, thermal stability, flammability, mechanical, and IP tests. To date, UDEM states it has issued 64,086 certificates and served 38,585 customers over 20+ years of operation.

UDEM generates revenue through professional services fees charged per application, per audit, per test, and on an annual surveillance basis under multi-year contracts. Pricing is project-based and varies by product scope, risk class, and regulatory requirement, with a published MDR Standard Fee List and a 10% group-registration discount for training. The company employs 51-100 staff and operates through a direct enterprise field sales motion targeting medical device manufacturers (primary), industrial/manufacturing companies, and dental sector clients. Lead generation and relationship development occur through active participation in major international trade shows including Expomed Eurasia, WHX Dubai, WHX Miami, IDEX Istanbul, and Tüyap, supplemented by SEO-optimized service pages, blog content, social media, and a customer portal.

UDEM's geographic reach extends beyond Turkey through wholly-owned regional liaison offices: UDEM Pacific Co., Ltd. (Seoul, South Korea), UDEM Shanghai Technical Services Co., Ltd. (Shanghai, China), and UDEM Atlantic L.L.C. (Medford, Massachusetts, USA). The company has a strategic collaboration with GUTcert GmbH for carbon footprint verification services, a dedicated career portal (hr.udem.com.tr), and has hosted delegations including the Malaysia Health Ministry Medical Device Authority. Ownership is private with no parent company or institutional investors disclosed.

Name

UDEM

Legal name

UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi Sanayi ve Ticaret Anonim Şirketi (UDEM A.Ş.)

Website

https://udem.com.tr

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

101–250 employees

Short description

UDEM is a Turkey-based EU Notified Body (2292) and TÜRKAK-accredited certification company providing MDR, ISO 13485, CE marking, and LVD testing services to medical device manufacturers and industrial companies, with regional offices in South Korea, China, and the United States.

Ownership category

akta.pro rank

Headquarters

HQ city

Ankara

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Conformity Assessment & Certification Services: UDEM generates revenue primarily through fees charged for conformity assessment, certification, testing, and auditing services. These include MDR certification, ISO 13485 system certification, CE marking for machinery/elevators/construction products, and LVD testing. Fees are charged per application, per audit, per test, and on an annual surveillance basis.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

UDEM is an EU Notified Body (2292) and TÜRKAK-accredited certification company that provides conformity assessment, product certification, and testing services enabling manufacturers to place products on the EU and Turkish markets. Its core offerings include CE marking, machine safety certification, elevator certification, ISO 13485 medical device quality management system certification, MDR conformity assessment, and LVD testing, complemented by environmental testing and regulatory training courses.

Product overview

UDEM operates as a unified platform offering a portfolio of certification and testing services. The core offering consists of product certification (CE Belgelendirme) as the primary platform, supplemented by specialized certification modules for machine safety (Makine Emniyeti Belgelendirme), elevator safety (Asansör Belgelendirme), and medical device quality management systems (ISO 13485 Belgelendirme). Environmental testing services (Çevre Test ve Ölçüm Hizmetleri) support these certification workflows by providing required technical measurement data. Training courses (Tıbbi Cihaz Yazılım Doğrulama Eğitimi and Ürün Belgelendirme Eğitimi) are offered as add-on educational modules to complement the certification services. The company holds TÜRKAK accreditation and serves clients across Turkey, South Korea, China, USA, and Europe.

Differentiator

Problem solved

Functional benefit

Products and services

• CE Belgelendirme (Product Certification / CE Marking) CE marking certification service enabling products to be placed on the European market in compliance with applicable EU directives, covering medical devices, machinery, elevators, and construction products.
• Makine Emniyeti Belgelendirme (Machine Safety Certification) Certification service for machinery safety under EU Directive 2006/42/AT, ensuring machinery meets required safety standards for placement on the European market.
• Asansör Belgelendirme (Elevator Certification) Certification service for elevator safety under EU Directive 2014/33/EU, verifying elevators meet the required safety and quality standards for market access.
• ISO 13485 Belgelendirme (Medical Device QMS Certification) Certification service for medical device quality management systems based on EN ISO 13485:2016 standard, awarded under TÜRKAK accreditation, demonstrating compliance with quality requirements for medical device manufacturers.
• Tıbbi Cihaz Yazılım Doğrulama Eğitimi (Medical Device Software Verification Training) Instructor-led training course covering medical device software validation requirements under EN 62304 standard, addressing risk management (ISO 14971), biological evaluation (ISO 10993-1:2020), and cybersecurity for software-based medical devices.
• Ürün Belgelendirme Eğitimi (Product Certification Training) Training course focused on product certification processes, CE marking procedures, and regulatory compliance requirements for bringing products to the European market.
• MDR Article 117 Notified Body Opinion (NBOp) Service NBOp service under MDR Article 117 for drug-device combination products, evaluating the device component's compliance with General Safety and Performance Requirements (GSPR) before manufacturers place such products on the EU market as integrated devices.
• LVD Test ve Ölçüm Hizmetleri (Low Voltage Directive Testing) Accredited electrical safety testing laboratory service under TS EN ISO 17025, performing insulation, leakage current, high voltage, grounding continuity, temperature, thermal stability, flammability, mechanical, and IP tests.

Quantifiable outcome

• Over 64,000 certificates issued to date
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and regional_hq.

• GUTcert GmbHcoreStrategic or Co-development PartnerUDEM Belgelendirme has a strategic collaboration with GUTcert GmbH (an international certification body) to provide carbon footprint verification services. Under the partnership, GUTcert supports UDEM's carbon footprint validation services, enabling UDEM to offer comprehensive carbon footprint verification and certification to Turkish businesses seeking to comply with EU carbon border mechanisms and ISO 14067 standards.
• UDEM Pacific Co. Ltd.regional_hqOthersUDEM Pacific Co. Ltd. is UDEM's international contact office based in Seoul, South Korea. It serves as a regional liaison for Korean medical device and industrial product manufacturers seeking UDEM's conformity assessment and certification services.
• UDEM Shanghai Technical Services Co., Ltd.regional_hqOthersUDEM Shanghai Technical Services Co., Ltd. is UDEM's international contact office in Shanghai, China. It serves as a regional liaison for Chinese manufacturers seeking UDEM's conformity assessment and certification services for EU market access.
• UDEM Atlantic L.L.C.regional_hqOthersUDEM Atlantic L.L.C. is UDEM's international contact office in Medford, Massachusetts, USA. It serves as a regional liaison for US-based manufacturers seeking UDEM's conformity assessment and certification services for EU market access.
• TÜRKAK (Türk Akreditasyon Kurumu)coreStrategic or Co-development PartnerUDEM operates a TÜRKAK-accredited LVD testing laboratory under TS EN ISO 17025 and holds TÜRKAK accreditation for ISO 13485 system certification. TÜRKAK provides the formal national accreditation that underpins UDEM's testing and certification credibility.

Scale indicators3 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• SGS: SGS is a Swiss-based global TIC company providing testing, inspection, and certification services including ISO 13485, CE marking, and product safety testing. It directly competes with UDEM across industrial and medical device certification markets.
• DEKRA: DEKRA is a German-based TIC company designated as EU Notified Body for multiple directives including machinery and product safety. It is a direct competitor to UDEM in product certification and testing services for European and global manufacturers across industrial and medical device verticals.
• DNV: DNV is a Norway-based TIC firm providing certification, testing, and inspection services including ISO 13485 and CE marking. It is a direct peer to UDEM for medical device and industrial certification services, particularly for manufacturers seeking EU market access.
• BSI Group: BSI Group is a UK-based TIC firm designated as EU Notified Body for MDR and provides ISO 13485 certification. It directly competes with UDEM in medical device quality management certification and CE marking services for manufacturers targeting the European market.
• Element Materials Testing: Element Materials Testing is a global testing laboratory network providing product testing, certification support, and failure analysis for industrial and medical device manufacturers. It is a direct peer to UDEM in product testing and certification testing services, with comparable laboratory-centric service model.
• Bureau Veritas: Bureau Veritas is a global TIC company providing conformity assessment, testing, and certification services including CE marking, ISO certifications, and product testing. It is a direct peer to UDEM in industrial and medical device conformity assessment and CE marking for manufacturers worldwide.
• Intertek: Intertek is a global TIC firm providing product testing, certification, and assurance services including CE marking, ISO 13485, and medical device conformity assessment. It directly competes with UDEM for testing and certification contracts across multiple manufacturing verticals and geographic regions.
• Kiwa: Kiwa is a Netherlands-based TIC company designated as EU Notified Body for multiple directives. It is a direct competitor to UDEM in product certification, testing, and CE marking for industrial and medical device manufacturers, with comparable mid-sized Notified Body positioning.
• TÜV Rheinland: TÜV Rheinland is a global TIC company designated as EU Notified Body for MDR, Machinery, and Elevator directives — the same set of directives UDEM covers. It is a direct competitor for medical device and industrial manufacturer conformity assessment and operates at significantly larger scale.
• TÜV SÜD: TÜV SÜD is a global TIC company and EU Notified Body designated for MDR (2017/745), machinery, and other EU directives. It directly competes with UDEM in medical device conformity assessment, CE marking, and ISO 13485 certification, serving overlapping manufacturer client bases across Europe, Asia, and the Middle East.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/udem-international-certification
• Xx.com/udemudem

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about UDEM