Introducing WiseLab, a specialized institution for medical device and IoT cybersecurity testing.
Greetings, I am Juyong Yun, CEO of WiseLab.
As digital transformation accelerates, cybersecurity for medical devices has become not an option but a necessity. We live in an era where a single vulnerability in a network-connected medical device can threaten an entire hospital system and, ultimately, patient lives.
As an ISO/IEC 17025 testing laboratory, WiseLab goes beyond simple vulnerability diagnosis to provide one-stop support from testing to regulatory submission document preparation enabling manufacturers to pass each country's regulations and bring safe products to market.
Fair and independent testing, reliable results grounded in standards. This is the promise WiseLab upholds.
We don't just find vulnerabilities.
We stand with manufacturers through the entire journey from regulatory compliance to delivering safe products to patients.
Patient safety, clinical workflows, and standardized evidence required by regulatory authorities. All three pillars must be satisfied to achieve regulatory approval. WiseLab delivers test reports at a level that can be submitted directly without additional processing.
Manufacturers focus on product development while WiseLab handles regulatory response. We provide one-stop support covering test execution, report preparation, and regulatory consulting.
We address major international standards including IEC 81001-5-1, ETSI EN 303 645, EN 18031, UL 2900, OWASP, and FDA Premarket.
Patient safety is the criterion for every testing decision. We always consider first how technical vulnerabilities can translate into risks in the clinical environment.
Test reports must serve as regulatory submission documents in their own right. We ensure that evidence mapped to international standards can be used directly without additional processing.
We maintain a testing environment and methodology independent from manufacturers. The objectivity of test results directly translates into trust from regulatory authorities.
WiseCompany Cybersecurity Testing Laboratory operates a management system compliant with ISO/IEC 17025:2017 requirements, providing fair and reliable testing services to customers, and aspires to be a global cybersecurity testing institution that achieves customer satisfaction.
The CEO is responsible for ensuring independence from the exercise of authority or undue internal and external pressures that may affect test results.
The CEO holds responsibility and authority over the entire management system and ensures that any interference that could affect the fairness and reliability of testing activities is eliminated.
We maintain independence from commercial, financial, or other external pressures and strive to ensure the objectivity and independence of testing activities.