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Find a pentest company with ISO 13485

35 companies have this certification

ISO 13485 and Cybersecurity/IT


Origin


ISO 13485 was developed by the International Organization for Standardization (ISO) and first published in 1996, with major revisions in 2003 and 2016. However, it's important to note that ISO 13485 is specifically a quality management system standard for medical devices and their related services—it is not primarily a cybersecurity or IT certification. The standard was created to help medical device manufacturers demonstrate their ability to provide devices and related services that consistently meet customer and regulatory requirements.


Industry Value


ISO 13485 is highly valued in the medical device industry because it provides a comprehensive framework for quality management that is recognized globally by regulatory authorities. Certification demonstrates an organization's commitment to product safety, regulatory compliance, and continuous improvement. While the standard itself focuses on quality management rather than cybersecurity specifically, the 2016 revision does address risk management throughout the product lifecycle, which can include cybersecurity considerations for software-based medical devices. For companies seeking to market medical devices internationally, ISO 13485 certification is often essential for regulatory approval and building customer confidence.

Blue Goat Cyber

Blue Goat Cyber

Medical Device Penetration Tes...
Scottsdale, United States 22 employees

Blue Goat Cyber is a private medical equipment manufacturing company specializing in medical device cybersecurity, including penetration testing and documentation for FDA premarket submissions and post-market management; founded in 2022, with 11 employees (+120% YoY growth), headquartered in Scottsdale, Arizona, USA. The company offers full-service cybersecurity solutions for medical device manufacturers, emphasizing FDA compliance and penetration testing, and has a growing online presence with recent awards and industry leadership in MedTech cybersecurity.

Full-service Medical Device Cybersecurity Including Penetration Testing
Risk Documentation
Threat Modeling
+3 more
THE ATOM GROUP

THE ATOM GROUP

Red Team Penetration Testing
Portsmouth, United States 20 employees

Private software development company founded in 2007; based in Portsmouth, NH, USA; 15 employees (+5.3% YoY growth); $6.5M annual revenue; specializes in software innovation and cybersecurity, including penetration testing with red-team style assessments; active in mobile, web, ecommerce, UX, CMS, security, and compliance sectors; recent partnerships and industry news.

Penetration Testing
Vulnerability Assessment
Red Team/blue Team Exercises
+2 more
AIT Austrian Institute of Technology

AIT Austrian Institute of Technology

Penetration Testing & Red Team...
Vienna, Austria 1155 employees

Austria's largest Research and Technology Organization (RTO) with 812 employees; founded in 2009 and headquartered in Vienna, Austria; generates approximately $4.6M annual revenue; offers research services including penetration testing and red teaming, with a global presence and active engagement in AI, biotech, and regional innovation.

Provides Penetration Testing
Red Teaming
Cybersecurity Research
+1 more
ISO Certification in Bulgaria

ISO Certification in Bulgaria

ISO Certification and Cybersec...
Bulgaria 11 employees

Bulgarian-based consulting and certification firm specializing in ISO standards and cybersecurity testing; offers penetration testing, VAPT, and application security services with a focus on Bulgaria, supported by explicit location references and a Bulgarian address.

ISO Certification Consulting
SOC Certification
GDPR Certification
+5 more
ISO Certification in Croatia

ISO Certification in Croatia

Network and Infrastructure Pen...
Croatia 51 employees

Croatian consulting firm based in Zagreb offering ISO certification services and penetration testing; provides network and infrastructure pentests, vulnerability assessments, and red-team simulations, demonstrating technical expertise in cybersecurity testing.

ISO Certification Consulting
Penetration Testing
Vulnerability Assessment
+2 more
TopCertifier

TopCertifier

Vulnerability Assessment and P...
Republic of Cyprus 11 employees

Cyprus-based ISO certification and VAPT (Vulnerability Assessment and Penetration Testing) consulting company; provides ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, ISO 22301, HACCP, and CMMI certifications; located at 81-83 Grivas Digenis Ave, Nicosia, open Monday to Saturday from 8am to 8pm, offering hassle-free certification and penetration testing services.

Iso 9001 Certification
Iso 14001 Certification
Iso 45001 Certification
+5 more
ISO Certification Estonia

ISO Certification Estonia

Network Penetration Testing
Estonia

Estonian-based certification consultancy located in Tallinn; offers ISO certification services with a focus on simplifying and expediting the process, and provides penetration testing services including network, infrastructure, and vulnerability assessments. Contact details include address, phone, and email.

ISO Certification
CMMI Certification
CE Marking
+5 more
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Solita

Solita

application security testing
Tampere, Finland 1764 employees

Solita is a Finland-based IT services and consulting firm with 1,262 employees and $185.5M annual revenue, founded in 1996. It offers a comprehensive portfolio from strategic consulting to AI and software development, emphasizing impact and customer value. The company explicitly provides penetration testing services, including automated testing (DAST), as part of its cybersecurity solutions.

Strategic Consulting
Service Design
Software Development
+3 more
Huld

Huld

cloud and application penetrat...
Finland 404 employees

Finnish technology consulting firm specializing in digital transformation, innovation, and security; headquartered in Espoo, Finland, with 11 offices in Finland and the Czech Republic; provides penetration testing and cybersecurity services, including security testing and cloud environment assessments.

Digital Services And Software
Product Design And Development
Embedded Solutions
+2 more
Tieto

Tieto

web application and network pe...
Finland 14693 employees

Finnish IT services company headquartered in Espoo/Helsinki; part of Tietoevry, which provides penetration testing and cybersecurity services, including active pentest projects for clients like ING Bank; known for building the future of technology with a focus on growth and innovation.

Banking Systems Solutions
Health And Social Care Technology
Industry-specific Software Solutions
+4 more
Tietoevry

Tietoevry

black-box and white-box penetr...
Finland 14693 employees

Finland-based technology company headquartered in Helsinki; provides digital transformation and cybersecurity services, including penetration testing (pentest) and attack simulations, with documented client engagements and third-party testing collaborations.

Digital Transformation
Cybersecurity Services
Penetration Testing
+5 more
DEKRA

DEKRA

Network Penetration Testing
Stuttgart, Germany 14304 employees

DEKRA is a Germany-based global safety and testing organization with 3,224 employees and $4.5B revenue; specializes in testing, inspection, certification, and cybersecurity services including penetration testing, with operations in over 50 countries and recent acquisitions.

Provides Penetration Testing
Cybersecurity Consulting
Battery Compliance Certification
+4 more
Berlin Cert GmbH

Berlin Cert GmbH

Web Application Pentesting
Berlin, Germany 15 employees

Berlin Cert GmbH is a public safety company based in Berlin, Germany, with 8 employees and founded in 1915; it offers accredited testing and certification services for medical products and explicitly provides penetration testing, including web application pentests with scope covering OWASP Top 10, supported by detailed service documentation. Part of the AFNOR Group, it specializes in medical device certification, accreditation, and IT security assessments.

Provides Penetration Testing
IT Security Assessments
Certification For Medical Devices
+1 more
ISO CERTIFICATION IN GREECE

ISO CERTIFICATION IN GREECE

Network and Infrastructure Pen...
Greece 24 employees

Greece-based cybersecurity firm specializing in penetration testing and VAPT certifications; located at 15, Theanous Str, Athens, with active service pages for network and infrastructure penetration testing, and VAPT certification.

ISO Certification (iso 9001
ISO 14001
ISO 27001
+5 more
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PRIORITY

PRIORITY

Penetration Testing and Red Te...
Greece 159 employees

PRIORITY is a Greece-based private business consulting and services company specializing in GDPR compliance, data protection, ISO management systems, and penetration testing; with 85 employees, 8.2% YoY growth, founded in 1995, and explicit penetration testing services including red teaming, vulnerability assessment, and forensics.

GDPR Compliance
AI Act Consulting
ESG & Sustainability
+5 more
QTICS GROUP

QTICS GROUP

Testing, Inspection, and Certi...
Budapest, Hungary 51 employees

QTICS GROUP is a private business consulting and services company based in Budapest, Hungary, founded in 2021; with 4 employees and a 12.5% YoY workforce decline. The firm offers a broad range of services including cybersecurity, digital simulation, and IoT, and explicitly provides penetration testing and vulnerability testing services aligned with OWASP Top 10 and MITRE ATT&CK frameworks, emphasizing its expertise in security evaluation.

Certification
Clinical Investigation
Condition Monitoring And Testing
+5 more
Top Certifier

Top Certifier

ISO Certification Consulting a...
Hungary 11 employees

Hungary-based certification and consulting firm specializing in ISO standards and penetration testing; operates in Budapest and other Hungarian cities; offers ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 22000, ISO 22301 certifications and pentest services, including VAPT certification and network penetration testing.

ISO Certification Consulting
Penetration Testing
Vulnerability Assessment
+5 more
I

iso-certification-latvia.com

Network Penetration Testing
Latvia 24 employees

Latvia-based ISO certification company TopCertifier offers services across Latvia, with a Riga address (Terbatas iela 14, Riga, LV-1011). The company also provides network penetration testing, including vulnerability exploitation, detailed reports, and remediation advice.

ISO Certification Consulting
Iso 9001 Certification
Iso 14001 Certification
+5 more
ISO, CE Mark, VAPT & HACCP Certification in Lithuania

ISO, CE Mark, VAPT & HACCP Certification in Lithuania

Vulnerability Assessment & Pen...
Lithuania 11 employees

Lithuanian-based certification provider located at 44A Gedimino avenue, Vilnius; offers ISO, CE Mark, VAPT, and HACCP certifications. Provides active penetration testing (VAPT) services, including vulnerability assessment and security testing, with a focus on compliance and security standards.

ISO Certification
CE Mark Certification
Vulnerability Assessment And Penetration Testing (vapt)
+3 more
TopCertifier

TopCertifier

ISO Certification and Vulnerab...
Malta 11 employees

Malta-based certification company providing ISO, HACCP, and VAPT services; offers penetration testing including vulnerability assessment, network, and application security testing; located at Dragonara Business Centre, St Julian's, Malta.

ISO Certification
HACCP Certification
CMMI Certification
+5 more
Kiwa

Kiwa

Tailormade Penetration Testing
Rijswijk, Netherlands 4158 employees

Kiwa is a private professional services company specializing in Testing, Inspection, Certification (TIC), and Training; with 790 employees (+11.3% YoY growth), $1.5B annual revenue, headquartered in Rijswijk, Netherlands. Kiwa offers penetration testing and ethical hacking services, conducting tailored simulated cyberattacks to identify vulnerabilities through structured phases including scoping, intelligence gathering, exploitation, and reporting, establishing itself as a global leader in TIC and cybersecurity testing.

Kiwa Provides Comprehensive Testing
Inspection
Certification Services
+5 more
Digiteum

Digiteum

Security and Penetration Testi...
Poland 54 employees

Poland-based software development company specializing in full-cycle custom software development and quality engineering, including penetration testing and security testing; registered in Gdańsk with KRS 0000866372 and address Ul. Szafarnia 11/F8, 80-755 Gdańsk.

Provides Full-cycle Custom Software Development
Quality Engineering Including Penetration Testing And Security Testing
Web And Mobile Development
+5 more
Spyrosoft

Spyrosoft

Comprehensive Penetration Test...
Wrocław, Poland 1141 employees

IT services and consulting company based in Poland; provides software development and penetration testing services with CREST accreditation; 912 employees (+14.6% YoY growth), PLN 465.4M revenue, founded 2016, headquartered in Wrocław, Poland; global rank #421,197, local rank #29,872.

Provides Consulting
Bespoke Software Development
Digital Transformation Services
+5 more
Innowise

Innowise

Comprehensive Penetration Test...
Poland 3500 employees

Innowise is a Poland-based software development company founded in 2007, with headquarters in Warsaw. It offers comprehensive software development services from ideation to DevOps, and provides penetration testing and cybersecurity services, supported by dedicated web pages detailing their security testing capabilities.

Provides Full-cycle Software Development
IT Consulting
Software Testing And QA
+4 more
DeviQA | Software Testing & QA Services Company

DeviQA | Software Testing & QA Services Company

Web Application, API, Network,...
Warsaw, Poland 114 employees

DeviQA is a Poland-based IT services and consulting firm specializing in software testing and quality assurance, with 52 employees and over 15 years of experience. It offers automated testing for web and mobile platforms and provides penetration testing services, including web app, API, network, cloud, and social engineering testing, with flexible service models such as staff augmentation, dedicated security teams, and project outsourcing.

Provides Comprehensive Software Testing And Quality Assurance Services Including QA Outsourcing
Consulting
Team Augmentation
+5 more
BetterQA

BetterQA

Application Security Penetrati...
Romania 50 employees

Romanian software testing company headquartered in Cluj-Napoca; provides quality assurance and cybersecurity services including penetration testing, with a focus on security testing, simulated attacks, and web security.

Embedded QA
Manual Testing
Test Automation
+5 more
TopCertifier

TopCertifier

Network Penetration Testing
Slovakia 11 employees

Slovakian-based cybersecurity consulting firm specializing in ISO, CE Mark, VAPT, and HACCP certifications; offers penetration testing services including network penetration testing in Slovakia; located at Apollo Business Centre II, Bratislava, with contact options via phone and email.

ISO Certification (including ISO 9001
ISO 14001
ISO 45001
+5 more
GlobalLogic

GlobalLogic

Automotive and AI Cybersecurit...
Slovakia 33500 employees

GlobalLogic is a Slovakia-based digital product engineering company specializing in software development, product strategy, and experience design; it explicitly offers penetration testing and offensive security services, with dedicated roles and references to pentest activities on its site.

Product Strategy & Experience Design
Digital Business Transformation
Intelligence Engineering
+4 more
SpectraSec

SpectraSec

Social Engineering Attack Simu...
Granada, Spain 5 employees

SpectraSec is a Spain-based IT services and cybersecurity consulting firm specializing in attack simulations such as phishing, smishing, and vishing, which are forms of penetration testing; founded in 2025 with 2 employees, it focuses on protecting health sector data through technology, training, and expert consulting.

Penetration Testing (simulated Phishing
Smishing
Vishing Attacks)
+5 more
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MedSecTesting

MedSecTesting

Medical Device Penetration Tes...
South Brisbane, Australia 4 employees

Cybersecurity testing company for medical devices; provides penetration testing, code reviews, reverse engineering, and cloud configuration services; founded 2023; 2 employees; based in South Brisbane, Australia; follows OWASP, CIS, ISO, TGA, FDA, and MDR standards.

Provides Penetration Testing
Source Code Analysis
Cloud Infrastructure Security Assessment
+5 more
CSIRO

CSIRO

Automated Network Pentesting
Acton, Australia 6931 employees

CSIRO is a government-funded research organization in Australia with 4,002 employees and $1.0B annual revenue; it has a long history of scientific innovation and conducts research across sectors including energy, space, and AI. The organization also offers cybersecurity services such as penetration testing and vulnerability assessments, supported by credible sources.

Provides Penetration Testing
Vulnerability Assessments
Red Teaming
+2 more
ZF Consulting Services

ZF Consulting Services

Infrastructure Penetration Tes...
Australia

Australian cybersecurity firm based in Brisbane; provides penetration testing, automation, and performance testing services to protect infrastructure; supports medical device industry with quality management systems; external sources confirm pentest offerings and Australian HQ.

Provides Penetration Testing
Automation
Performance Testing
+1 more
Solitech Inovações Industriais

Solitech Inovações Industriais

Network
Brazil 7 employees

Cybersecurity firm specializing in penetration testing, advisory, and risk management; 2 employees with 16.7% YoY growth; headquartered in Brazil, with a focus on cybersecurity strategy and innovation support.

Industrial Maintenance
Industrial Automation
Engineering
+5 more
Mtechnix Sdn. Bhd.

Mtechnix Sdn. Bhd.

ics/scada system penetration t...
Malaysia 5 employees

Malaysian cybersecurity and engineering firm specializing in OT & IT cybersecurity, engineering services, ISO certifications, project management, and professional training; provides penetration testing for networks, web, mobile, and ICS/SCADA systems, including red team exercises.

Ot Cybersecurity
IT Cybersecurity
Engineering Services
+4 more
Infosys

Infosys

application penetration testin...
Bangalore, India 362415 employees

Global IT services and consulting firm based in Bangalore, India, with 210,146 employees and $19.8B annual revenue; offers next-generation digital transformation and cybersecurity services, including CREST-certified penetration testing and vulnerability assessments; founded in 1981, market cap INR 7.55 trillion, with recent acquisitions and a strong international presence.

Next-generation Digital Services And Consulting
Cybersecurity Including Penetration Testing And Vulnerability Assessment
Cloud Services
+3 more