Berlin Cert
Berlin Cert GmbH is a Berlin-based EU Notified Body providing MDR conformity assessment, EN ISO 13485, and DiGA certification for medical device manufacturers, plus penetration testing and IT security assessments, serving healthcare and critical infrastructure clients across Europe via its GUTcert/AFNOR Group affiliation.
- Company typePrivate
- Founded2001
- HeadquartersBerlin, Germany
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Berlin Cert does
Berlin Cert GmbH is a Berlin-based certification body and IT security testing laboratory that operates as a wholly owned subsidiary of GUTcert, itself part of the international AFNOR Group. The company is designated as a Notified Body under EU Medical Device Regulation 2017/745 (since 2022, previously under MDD 93/42/EEC since 1997) and is DAkkS-accredited for EN ISO 13485 quality management system certification. Its core product lines are MDR conformity assessment, EN ISO 13485 certification, DiGA certification for German digital health applications, and a tiered IT security testing portfolio that includes Cyber-Security-Check, Rapid Test, Interface Testing, and Web Application Penetration Tests conducted under PTES, OWASP, and BSI methodologies. Combined management system certifications (ISO 9001, 14001, 27001, 45001, 50001) are delivered through the GUTcert partnership as if from a single certification body.
The company operates a direct enterprise sales motion with request-for-quote intake, free consultation hours, and project coordinator engagement, targeting medical device manufacturers, medical device suppliers, healthcare organizations, technology companies, and critical infrastructure operators in Europe and EMEA. Pricing is quote-based and tailored to scope; certification revenue recurs on a 3-year cycle with annual surveillance audits, while IT security testing is project-based. Marketing reaches customers via LinkedIn, GUTcert-managed newsletters, webinars, the company website, and industry events such as DMEA.
Berlin Cert traces its institutional history to a 1915 testing centre for prosthetic limbs at TU Berlin, was incorporated as Berlin Cert GmbH in 2001, and reorganized in 2016 under GUTcert/AFNOR Group ownership. In 2024 it closed its electrical and mechanical testing laboratory, refocusing on certification and IT security assessment. The company employs 11-50 people and is led by Managing Directors Johannes Lieback and Jan Uwe Lieback.
Berlin Cert firmographics
Firmographics- Name
- Berlin Cert
- Legal name
- Berlin Cert GmbH
- Website
- https://berlincert.de
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Berlin Cert GmbH is a Berlin-based EU Notified Body providing MDR conformity assessment, EN ISO 13485, and DiGA certification for medical device manufacturers, plus penetration testing and IT security assessments, serving healthcare and critical infrastructure clients across Europe via its GUTcert/AFNOR Group affiliation.
- Ownership category
- akta.pro rank
Berlin Cert industry classification
Industry- Product category
- Medical Device Certification and Conformity Assessment
- NAICS
- Testing Laboratories and Services (54138), Professional, Scientific, and Technical Services (541)
- SIC
- Services-Testing Laboratories (8734)
- akta.pro primary industry
- Standards, Metrology & Accreditation Bodies (BPAIAOAC)
Keywords
Where Berlin Cert is headquartered
LocationHeadquarters
- HQ city
- Berlin
- HQ country
- Germany
- HQ region
- Europe
Offices1 record
Markets served
Berlin Cert business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Others
Revenue model
- Certification Services: Recurring certification fees for medical device conformity assessment (MDR), quality management system certification (ISO 13485), and related management system certifications. Certification operates on a 3-year cycle with annual surveillance audits.
- IT Security Testing Services: Penetration testing, cyber-security checks, rapid tests, interface testing, and web application penetration testing. Provided as project-based engagements with scope-dependent pricing.
- Combined/Integrated Certifications: Bundle certifications including ISO 9001, ISO 14001, ISO 45001, ISO 50001, and ISO/IEC 27001 through partnership with GUTcert, offered as comprehensive certification packages.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Custom project-based pricing for IT security testing |
| Other | Multi-year contract | Certification fee schedule available upon request |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
Berlin Cert product offering
Product offeringCore offering
Berlin Cert provides certification, conformity assessment, and testing services as a Notified Body designated under EU Medical Device Regulation 2017/745. Its portfolio covers MDR conformity assessment and EN ISO 13485 quality management system certification for medical device manufacturers, DiGA certification for digital health applications, and a tiered suite of IT security services including the Cyber-Security-Check, Rapid Test, Interface Testing, and Web Application Penetration Test, supported by combined management system certifications through GUTcert.
Product overview
Berlin Cert offers a portfolio of testing, certification, and conformity assessment services organized in two core areas: medical device certification and IT security testing. For medical devices, the primary offerings are MDR Conformity Assessment and EN ISO 13485 Certification, which can be supplemented by DiGA certification for digital health applications and combined certifications for broader management system standards (ISO 9001, ISO 14001, ISO 27001, etc.) delivered through the GUTcert partnership. For IT security, Berlin Cert provides a tiered set of penetration testing and security assessment services including the Cyber-Security-Check, Rapid Test, Interface Testing, and Web Application Penetration Test — each targeting different depths and scopes of security evaluation. An optional Change Service supports companies switching from other certification bodies.
Differentiator
Problem solved
Functional benefit
Products and services
- MDR Conformity Assessment EU Medical Device Regulation (MDR) conformity assessment and certification services for medical devices, conducted as a Notified Body designated under Regulation (EU) 2017/745. For medical device manufacturers seeking CE marking.
- EN ISO 13485 Certification Quality management system certification for medical device manufacturers and suppliers based on the EN ISO 13485 standard, covering the full value chain from development to distribution.
- DiGA Certification Certification services for Digital Health Applications (Digitale Gesundheitsanwendungen) in Germany, verifying data security and data protection requirements per the DiGAV regulation.
- Combined Certifications Additional management system certifications offered in combination with primary certifications, including ISO 9001, ISO 14001, ISO 45001, ISO 50001, and ISO/IEC 27001, delivered through partnership with GUTcert.
- Cyber-Security-Check IT security assessment service providing a low-threshold evaluation of an organization's cybersecurity posture, including recommendations for improvement and compliance alignment.
- Rapid Test (IT-Sicherheit Schnelltest) Quick-turnaround IT security testing service for rapid assessment of systems and applications, offering a fast overview of security vulnerabilities.
- Interface Testing (IT-Schnittstellen-Prüfung) Testing service focused on the security of system interfaces and APIs, verifying that connections between systems are properly secured and free from vulnerabilities.
- Web Application Penetration Test Comprehensive penetration testing service for web applications, conducted as Black-Box and Grey-Box tests following PTES standards, BSI guidelines, and OWASP Top 10 methodologies, targeting web applications, servers, and APIs.
- Change Service (Wechselservice) Switching service enabling companies to change their certification body to Berlin Cert mid-cycle or at recertification, including transfer of existing audit reports and combined audit options.
Companies that use Berlin Cert
Customer profileNamed customers7 records
Segments5 records
Ideal customer profiles3 records
Berlin Cert technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
Feature4 records
Berlin Cert partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- GUTcertcoreSince June 2016, Berlin Cert has been a wholly owned subsidiary of GUTcert. GUTcert provides access to a wider range of certification services including ISO 9001, ISO 14001, ISO 45001, ISO 50001, and ISO/IEC 27001. GUTcert also operates the GUTcert Academy for training and the newsletter service.
- AFNOR GroupcoreThrough GUTcert ownership, Berlin Cert is part of the AFNOR Group international network. This provides additional security through an internationally positioned expert network. The integration gives Berlin Cert access to global certification expertise and international market reach.
- GUTcert AkademieminorTraining partner providing seminars and educational programs for auditors and industry professionals. Some auditors also serve as trainers, sharing their practical experience in training content. Topics include ISO standards, IT security, energy management, and healthcare quality management.
- GUTcert (Combined Certifications)coreBerlin Cert refers customers to GUTcert for management system certifications outside their own scope (ISO 9001, ISO 14001, ISO 45001, ISO 50001) and for product and supply chain certifications (ISCC, REDcert, SURE). Combined audits can be conducted as if from a single certification body.
Scale indicators4 records
Recent moves8 records
Expansion highlights5 records
Berlin Cert competitors and assessment
Company assessmentBroad incumbents
- TÜV Rheinland: Global testing, inspection, and certification giant with designated Notified Body status under EU MDR for medical devices. Overlaps with Berlin Cert on medical device certification and IT security testing, with much broader geographic and vertical coverage.
- Eurofins: Global testing services group with extensive medical device testing, certification, and cybersecurity capabilities. Competes with Berlin Cert on the testing/conformity assessment side while offering far broader analytical testing services.
- DNV: Global certification body with healthcare/medical device certification services and significant IT security/cybersecurity practice. Directly comparable to Berlin Cert in ISO 13485 and management system certifications, with a much broader industry footprint.
- SGS: World's largest testing, inspection, and certification company with medical device certification services (ISO 13485, MDR/MDD) and IT security offerings. Overlaps with Berlin Cert across both certification and testing verticals at global scale.
- BSI Group: UK-headquartered standards and certification body operating as an EU MDR Notified Body for medical devices, with strong ISO 13485 and cybersecurity certification offerings. Comparable to Berlin Cert in regulated certification and IT security assessment.
- TÜV SÜD: One of the largest global notified bodies for medical devices (ISO 13485, MDR/MDD), operating across multiple industries and geographies. Directly comparable to Berlin Cert in MDR conformity assessment and ISO 13485 certification, but vastly larger in scale and scope.
- DEKRA: Major international certification body with medical device notified body services and a broad portfolio including IT security and cybersecurity certifications. Directly competes with Berlin Cert in the same regulated certification categories but at significantly larger scale.
Direct peers
- MEDCERT: Germany-based Notified Body for medical devices (MDR/MDD) and ISO 13485 certification body. Comparable mid-sized specialist competing head-to-head with Berlin Cert for German and European medical device manufacturer clients.
- mdc medical device certification GmbH: German medical device certification body and EU MDR Notified Body, headquartered in Germany. Closest direct competitor to Berlin Cert in terms of size, geography, and exclusive focus on medical device certification (ISO 13485, MDR).
- DQS Medizinprodukte GmbH: German medical device certification body (part of DQS Group) offering ISO 13485, MDR conformity assessment, and related management system certifications. Direct peer to Berlin Cert with similar specialization and geographic focus.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Berlin Cert social profiles
Digital presenceBerlin Cert compliance and trust
Trust signalCompliance2 records
Berlin Cert financial estimates
Financial estimateRevenue estimate
Valuation estimate
Berlin Cert leadership team
Management profileNumber of profiles
Profiles3 records
Berlin Cert funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Berlin Cert 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 Berlin Cert
What does Berlin Cert do?
Berlin Cert provides certification, conformity assessment, and testing services as a Notified Body designated under EU Medical Device Regulation 2017/745. Its portfolio covers MDR conformity assessment and EN ISO 13485 quality management system certification for medical device manufacturers, DiGA certification for digital health applications, and a tiered suite of IT security services including the Cyber-Security-Check, Rapid Test, Interface Testing, and Web Application Penetration Test, supported by combined management system certifications through GUTcert.
Is Berlin Cert a public or private company?
Berlin Cert is a private company. It is classified as corporate owned and is currently operating.
When was Berlin Cert founded?
Berlin Cert was founded in 2001. It employs 11 to 50 people.
Where is Berlin Cert based?
Berlin Cert is headquartered in Berlin, Germany, in the Europe region.
How does Berlin Cert make money?
Three revenue lines are on record. Certification Services are the primary driver. The others are IT Security Testing Services and combined/Integrated Certifications.
Who are Berlin Cert's main competitors?
Broad incumbents on record are TÜV Rheinland, Eurofins, DNV, SGS, BSI Group, TÜV SÜD and DEKRA. Direct peers are MEDCERT, mdc medical device certification GmbH and DQS Medizinprodukte GmbH.
Does Berlin Cert have an API?
No public API is recorded for Berlin Cert.
What industry is Berlin Cert in?
Berlin Cert's product category is Medical Device Certification and Conformity Assessment. Its primary akta.pro industry code is BPAIAOAC, Standards, Metrology & Accreditation Bodies. Its NAICS code is 54138 and its SIC code is 8734.