Velentiummedical
Velentiummedical is a specialized firm focused on medical device cybersecurity, ensuring the safety and security of connected healthcare technologies.
Velentiummedical is dedicated to safeguarding the integrity and security of medical devices within the healthcare ecosystem. They offer specialized expertise in medical device cybersecurity, addressing the unique challenges and vulnerabilities associated with connected health technologies. Their services are crucial for manufacturers and healthcare providers aiming to comply with stringent regulations and protect patient data from cyber threats. By focusing on this critical niche, Velentiummedical helps ensure that the advancements in medical technology are matched by robust security measures, fostering trust and reliability in digital healthcare solutions.
About
**Who they are**
Velentiummedical is a professional engineering firm specializing in medical device R&D, manufacturing, and cybersecurity. They focus on transforming intellectual property into safe and secure products.
**Expertise & scope**
* Class II & Class III Medical Device R&D
* Medical Device Manufacturing
* Medical Device Cybersecurity
* Medical Device Test Systems
* End-to-end services from concept to commercial launch
**Reputation / proof points**
* ISO 13485 Certified
* USA-based FDA registered manufacturer of record
* cGMP production
Velentiummedical is a professional engineering firm specializing in medical device R&D, manufacturing, and cybersecurity. They focus on transforming intellectual property into safe and secure products.
**Expertise & scope**
* Class II & Class III Medical Device R&D
* Medical Device Manufacturing
* Medical Device Cybersecurity
* Medical Device Test Systems
* End-to-end services from concept to commercial launch
**Reputation / proof points**
* ISO 13485 Certified
* USA-based FDA registered manufacturer of record
* cGMP production
Additional information
Velentiummedical positions itself as a comprehensive partner for medical device development, offering services that span from initial research and development through to contract manufacturing. Their capabilities include the design and production of Class II and Class III medical devices, emphasizing safety and security throughout the process. They also provide specialized services in medical device cybersecurity and automated test systems, aiming to support clients from concept to commercialization.
Key Highlights
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Specializes in Class II and Class III medical device R&D and manufacturing.
Source
“Velentium Medical designs and manufactures class II and class III medical devices for you.”
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Offers dedicated medical device cybersecurity services.
Source
“Medical Device Cybersecurity”
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Provides end-to-end services from concept to commercial launch.
Source
“End-to-End: from Concept to Commercial Launch”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking to integrate cybersecurity into product development.
- Companies requiring assistance with regulatory compliance for medical device security.
- Firms needing specialized training for engineering teams on embedded cybersecurity.
How engagement typically works
- End-to-end project support.
- Consultative approach to security requirements.
- Training and knowledge transfer.
Typical deliverables
- Security risk management plans.
- QMS policies and procedures.
- Vulnerability and penetration test reports.
- Cybersecurity training modules and artifacts.
- Traceable and testable security requirements.
Good to know
- Best when proactive integration of cybersecurity is a priority from the early stages of device development.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $595 per year for training subscription, $2,995 for master class.
Notes:
Based on publicly listed information for training; final fees for other services depend on scope.
“$2,995; $595 per year”
Languages:
English
Claim status:
Listed
Services & Capabilities
Medical Device Cybersecurity
Provider Type:
Service Firm
Service Categories:
Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage Support:
Ready for 510(k)/MDR Submission
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Standards Frameworks:
ISO 13485, MDR, FDA, HIPAA, NIST, IEC 62443, UL 2900
Pen Testing Available:
Yes
Threat Modeling Available:
Yes
Vulnerability Monitoring Available:
Yes
Additional medical_device_cybersecurity Details
Provider Type
service firm
Service Categories
Penetration Testing, Vulnerability Management
Device Types Supported
connected hardware
Standards Frameworks
IEC 81001-5-1, ISO 14971, NIST, AAMI
Submission Stage Support
Pre‑Submission
