a
- AAMI
- Accreditation
- Active Implantable Medical Device Directive
- AIMDD
- Algorithm
- App
b
- Breakthrough Device Designation
- BSI
c
- CDSS
- CEN
- CENELEC
- CJEU
- Classification
- Clinical Data
- Clinical Decision Support System
- Clinical Evaluation
- Clinical Evaluation Report
- Clinical Investigation
- Compiler
- Conformity Assessment
- Copyright
- Court of Justice of the European Union
- Cybersecurity
d
- DAkkS
- Data Portability
- Data Protection
- Data Security
- Delegated Acts
- Denial of Service
- Device Identifier
- DIN
- DKE
- DoS
e
- Embedded Software
- ETSI
- EU GDPR
- EU MDD
- EU MDR
- EUDAMED
f
- FDA
h
- Harmonized Standard
- Health Canada
- Health Data
- HMIS
- Hospital Management Information System
i
- IEC
- IEC 60601
- IEC 62304
- IEC 62366
- IEC 62443
- IEEE
- IMDRF
- Implementing Act
- Information Security
- Intended Purpose
- ISO
- ISO 13485
- ISO 14155
- ISO 14971
- ISO 27799
- ISO/IEC 27002
l
- Liability
- Linker
m
- Market Access
- MDCG
- MEDDEV
- Medical App
- Medical Device
- Medical Device Coordination Group
- Medical Software
- Medicines and Healthcare products Regulatory Agency
- MHRA
- MRI
n
- NHS
- Notified Body
o
- Official Journal of European Union
- OJEU
p
- Patient Data Management System
- PDMS
- Periodic Safety Update Report
- Personal Data
- Post-Market Surveillance
- Privacy by Default
- Privacy by Design
- Production Identifier
- PSUR
r
- Ransomware
- Risk Management
s
- SaMD
- Software as Medical Device
- Software Life Cycle
- Software Maintenance
- Standard
t
- Tool
- Traceability
- Transition Period
u
- UDI
- UDI-DI
- UDI-PI
- Unique Device Identifier
v
- Validation
- Verification
3 thoughts on “Glossary”
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I suggest a term “IEEE” as it is another organization that develops standards. ”
“IEEE is an internationally active technology association headquartered in New York, USA. IEEE publishes, hosts conferences, develops standards and promotes professional and educational activities.”
Thank you for your contribution, Morten. I have added the term.
In case the term “CYBERSECURITY” is underlined, the following pop-up-text is shown in case the mouse is placed above:
“Cybersecurity (information security) describes the freedom of potential harm (unauthorized access or modification of personal data or software data) caused by attacks on IT systems connected to the internet.”
I suggest to broaden the last part of the definition “… systems connected to the internet.” with respect to the (longer) definition in the glossary. Only “internet” seems not sufficient.
Kind regards,
Hans