What is a Medical Device Assessment
An independent technical diagnosis of your device
Many medical devices remain on the market for years while technologies, cybersecurity requirements and software dependencies continue to evolve.
The Medical Device Assessment provides management with an independent technical evaluation of the device’s current state, helping determine whether the product is still aligned with the state of the art and where intervention may be needed.
The analysis considers the device as a complete technical system, including hardware, firmware, software, cybersecurity and regulatory aspects.
Why this has become a critical topic
The medical device landscape is evolving rapidly. New cybersecurity requirements, regulatory updates and emerging technical practices are changing expectations for products already on the market.
Relevant technical references include, for example:
-
MDCG cybersecurity guidance for medical devices
-
risk management practices according to ISO 14971
-
software lifecycle requirements according to IEC 62304
-
new practices for vulnerability management and SBOM (Software Bill of Materials)
Devices designed only a few years ago may therefore no longer fully align with these expectations.
Areas of analysis
What a Medical Device Assessment analyzes
The assessment evaluates the device as a whole. Depending on the agreed scope, different technical dimensions can be analyzed.
Hardware and firmware architecture
Evaluation of the device’s technical structure and the long-term sustainability of design choices.
Software
and code
Analysis of software architecture, technology dependencies and — when available — source code.
Device
cybersecurity
Assessment of the system’s security posture and potential attack surfaces.
Regulatory and risk management aspects
Alignment between the technical architecture, risk management and regulatory requirements.
The result is a concise technical report designed to support management decisions.
Technical risks across the device lifecycle
Over time, technical issues can emerge that are not immediately visible.
The Medical Device Assessment helps identify these issues before planning product evolution.
Cybersecurity
risks
New standards and guidance require active management of vulnerabilities and software libraries.
Critical technology
dependencies
Frameworks, operating systems or hardware components may become obsolete or no longer supported.
Technical
obsolescence
Architectures designed years earlier may no longer reflect current best practices.
Component
availability
Hardware components or software libraries may become difficult to maintain or replace.
Typical situations
When a Medical Device Assessment is useful
An assessment is particularly useful when the device enters a new phase of its lifecycle.
-
when the device needs to evolve or be updated
-
when concerns arise around security or compliance
-
when the product architecture has accumulated complexity over time
Assessment output
Actual system condition
An objective picture of the device’s technical status.
Technical or regulatory issues
Structural problems or potential risks.
Intervention priorities
Guidance on where to intervene to improve the system.
Immediate quick fixes
Short-term actions that can reduce risk or technical complexity.
The process
How the Medical Device Assessment works
The assessment follows a structured process.
1.
Scope
definition
Identification of the components and aspects to analyze.
2.
Technical evidence
collection
Review of documentation and discussions with the team.
3.
Criticality
analysis
Technical evaluation and identification of key issues.
4.
Report
delivery
Presentation and discussion of the results with management.
Typical duration: 4–8 weeks.
Initial evaluation
Determine whether your device needs an assessment
Every device has its own technical history. For this reason, the assessment is configured based on the product and the required level of analysis.
The first step is a short evaluation call to determine whether the assessment makes sense for your device.
Why work with NRG
ISO 13485
Quality system certified for medical software development.
Experience with
complex systems
Devices integrating hardware, firmware and software.
Independent approach
A neutral technical evaluation of the product’s condition.
