MedSecTesting

MedSecTesting

Speciality: Medical Device Penetration Testing

South Brisbane, Australia 4 employees
[01] About

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.

CYBERSECURITY TESTING FOR MEDICAL DEVICES • Penetration testing for Software as a Medical Device and Medical Devices that include Software. • Penetration testing for Wearable and IoT Medical Devices. • Binary, dependencies, and source code analysis for security breaches. • Cloud infrastructure and backend security assessment. • Cybersecurity risk assessment compliant with FDA, TGA and EU MDR requirements. While testing, we follow regulatory bodies, OWASP, CIS and ISO security testing guidelines. Our team is certified Penetration Testers and Information Security professionals. We provide all the required documentation related to cybersecurity for your pre/post-market submission. We have completed numerous cybersecurity testing projects that have been successfully approved by FDA, TGA and EU MDR regulatory authorities. With us, you will be confident that there are no blocking security issues for your device to get on the market. Our approach: 1. Initial meeting to discuss high-level requirements. 2. Signing Non-disclosure (NDA) and Intellectual property (IP) agreements. 3. Gathering detailed requirements via: a. Meeting the core team, b. Existing documentation, c. Follow-up emails. 4. Preparing a detailed and compliant Test Plan. 5. Designing the most effective test cases for your device. 6. Executing the security testing according to the approved Test Plan. 7. Preparing technical test reports with findings and mitigation recommendations. 8. We assist your technical team addresses the issues according to the recommendations. 9. Our test team re-test the failed modules and prepare the final report
[02] Services
Provides Penetration Testing
Source Code Analysis
Cloud Infrastructure Security Assessment
Risk Assessment
Technical Design Gap Assessment For Medical Devices And Software
With Regulatory Compliance Support For FDA
TGA
EU MDR Requirements.
[03] Certifications
CISM

CISM Certification: Origin


The Certified Information Security Manager (CISM) certification was created by ISACA (Information Systems Audit and Control Association) in 2003. ISACA developed CISM to address the growing need for a certification specifically focused on information security management and governance, rather than just technical security skills. The certification was designed to recognize professionals who design, manage, and oversee an enterprise's information security program, filling a gap between technical security certifications and the strategic, managerial aspects of cybersecurity.


Industry Value and Importance


CISM is highly valued in the cybersecurity industry because it demonstrates expertise in security risk management, governance, incident management, and program development from a management perspective. Many organizations, particularly large enterprises and government agencies, specifically seek CISM-certified professionals for leadership roles in information security. The certification is globally recognized and often commands higher salaries compared to non-certified peers. Its focus on aligning security practices with business objectives makes it particularly relevant for professionals aspiring to senior security management positions, including Chief Information Security Officer (CISO) roles.

ISO 13485

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.

IEC 62304
ISO 27001

ISO 27001: Information Security Management Certification


Origin


ISO 27001 was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), and was first published in 2005. It evolved from the British Standard BS 7799-2, which was created in the late 1990s. The standard was developed in response to the growing need for organizations to systematically manage and protect sensitive information in an increasingly digital business environment. ISO 27001 has since been revised, with major updates released in 2013 and 2022 to address evolving cybersecurity threats and best practices.


Industry Value and Importance


ISO 27001 is globally recognized as the leading standard for information security management systems (ISMS) and is valued for providing a systematic, risk-based approach to protecting sensitive data. Organizations that achieve ISO 27001 certification demonstrate to clients, partners, and regulators that they have implemented comprehensive security controls and are committed to maintaining confidentiality, integrity, and availability of information. The certification is particularly important for organizations handling sensitive data, as it helps meet regulatory compliance requirements, reduces security incidents, builds customer trust, and often provides a competitive advantage in procurement processes where information security assurance is required.

ISO 9001

ISO 9001 and Cybersecurity/IT


Origin


ISO 9001 is a quality management system standard developed by the International Organization for Standardization (ISO), first published in 1987. However, it's important to note that ISO 9001 itself is not a cybersecurity or IT-specific certification—it's a general quality management standard applicable to any industry. For cybersecurity and IT specifically, ISO created ISO/IEC 27001 in 2005, which focuses on information security management systems. ISO 9001 was created to establish consistent quality management practices across organizations worldwide, while ISO/IEC 27001 was developed to address the growing need for standardized information security controls.


Industry Value


ISO 9001 is valued across industries for demonstrating an organization's commitment to quality, customer satisfaction, and continuous improvement, which can indirectly support IT operations. For actual cybersecurity and IT security certification, ISO/IEC 27001 is the recognized standard, valued because it provides a systematic approach to managing sensitive information, demonstrates due diligence to clients and stakeholders, and is often required for government contracts or business partnerships. ISO/IEC 27001 certification signals that an organization has implemented internationally recognized security controls and risk management processes, making it essential for building trust in an increasingly security-conscious business environment.

ISTQB
CISSP

CISSP Certification Overview


Origin


The Certified Information Systems Security Professional (CISSP) was created by the International Information System Security Certification Consortium, commonly known as (ISC)², in 1994. The certification was developed in response to the growing need for a standardized, vendor-neutral credential that could validate the expertise of information security professionals. (ISC)² designed the CISSP to establish a common body of knowledge for the cybersecurity field and provide a benchmark for measuring professional competence in information security.


Industry Value


The CISSP is widely regarded as one of the most prestigious and recognized certifications in cybersecurity, often required or preferred for senior-level security positions. Its value stems from its comprehensive coverage of eight security domains, including security operations, asset security, and security architecture, which demonstrates a candidate's broad expertise across the entire security landscape. The certification is accredited to ISO/IEC Standard 17024 and meets U.S. Department of Defense Directive 8570 requirements, making it particularly valuable for government contractors and enterprise organizations. Employers value CISSP-certified professionals because the rigorous examination process and experience requirements (minimum five years) ensure holders possess both theoretical knowledge and practical experience in managing and implementing security programs.

CISA

CISA Certification Overview


Origin and History


The Certified Information Systems Auditor (CISA) certification was created by ISACA (Information Systems Audit and Control Association) in 1978. ISACA developed this credential in response to the growing need for standardized expertise in auditing, controlling, and securing information systems. As one of the oldest IT audit and security certifications available, CISA was designed to validate the knowledge and skills of professionals responsible for assessing an organization's IT and business systems vulnerabilities and implementing appropriate controls.


Industry Value and Importance


CISA is highly valued in the industry because it demonstrates a professional's ability to assess risk, implement controls, and ensure compliance with regulatory requirements. The certification is globally recognized and often required or preferred for roles in IT audit, cybersecurity, risk management, and compliance positions. Many organizations, particularly financial institutions, government agencies, and publicly traded companies, specifically seek CISA-certified professionals to meet internal audit requirements and regulatory obligations. The credential's emphasis on both technical knowledge and practical application makes it particularly relevant for professionals who need to bridge the gap between IT operations and business governance.

GWAPT

GWAPT Cybersecurity Certification


Origin


The GIAC Web Application Penetration Tester (GWAPT) certification was created by the Global Information Assurance Certification (GIAC), an organization founded in 1999 as part of the SANS Institute. GIAC developed GWAPT to address the growing need for skilled professionals who could identify and exploit vulnerabilities in web applications. The certification was designed to validate hands-on technical skills in web application security testing, reflecting the real-world challenges that security professionals face when assessing modern web-based systems.


Industry Value


GWAPT is highly valued in the cybersecurity industry because it demonstrates practical expertise in web application penetration testing, one of the most critical areas of information security. Organizations prize this certification because holders have proven their ability to identify common and advanced vulnerabilities in web applications, which remain a primary attack vector for cybercriminals. The certification's emphasis on hands-on skills rather than just theoretical knowledge makes GWAPT holders particularly attractive to employers seeking security professionals who can immediately contribute to protecting their web-based assets and conducting thorough security assessments.

GCIH

GCIH Cybersecurity Certification


Origin


The GIAC Certified Incident Handler (GCIH) certification was created by the Global Information Assurance Certification (GIAC), which was founded in 1999. GIAC is part of the SANS Institute, a cooperative research and education organization established in 1989. The GCIH was developed to address the growing need for professionals who could effectively detect, respond to, and resolve computer security incidents. It was designed to validate practitioners' abilities to manage security incidents by understanding common attack techniques, vectors, and tools, as well as defend against and respond to such attacks when they occur.


Industry Value


The GCIH certification is highly valued in the cybersecurity industry because it demonstrates practical, hands-on knowledge of incident handling and response—critical skills as organizations face increasingly sophisticated cyber threats. Employers recognize GCIH holders as professionals capable of managing security incidents from detection through resolution, making them essential members of security operations centers (SOCs) and incident response teams. The certification is often required or preferred for positions in incident response, security analysis, and defensive security roles, and it meets Department of Defense (DoD) 8570 requirements for information assurance positions, further enhancing its recognition and value in both government and private sector organizations.

OSCP

Origin of the OSCP


The Offensive Security Certified Professional (OSCP) certification was created by Offensive Security, a company founded by Mati Aharoni and other security professionals in 2007. The certification was developed to address the gap between theoretical knowledge and practical penetration testing skills in the cybersecurity industry. Offensive Security designed the OSCP to be a hands-on, performance-based certification that requires candidates to demonstrate actual hacking skills in a controlled lab environment rather than simply answering multiple-choice questions.


Industry Value and Importance


The OSCP is highly valued in the cybersecurity industry because it proves that holders possess real-world penetration testing abilities. Unlike traditional certifications, the OSCP's 24-hour practical exam requires candidates to successfully compromise multiple machines in a simulated network environment and document their findings professionally. This hands-on approach has made it a gold standard for entry to intermediate-level penetration testers, and it's frequently requested or required by employers hiring for offensive security roles. The certification's difficulty and practical nature have earned it significant respect among security professionals and hiring managers.

GCPN
MDSAP
MDR
MDD