Tag: Design controls

Tag Visualization: Top 50 related tags by occurrence

Recent Related Articles to Design controls

2 Day Medical Device Design Control Course: Streamline Development and Guarantee Top ...

Added to Collection on: 2023-11-18 17:00:58

Tags for this article:

Regulation of medical devices
Pharmaceutical industry
Systems engineering
Quality management
Medical equipment
Quality management system
Design history file
Design controls
Medical device
Validation
Food and Drug Administration
Biomedical engineering

Click the tags to see associated articles and topics

View Article Details
FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO - JD Supra

Added to Collection on: 2024-03-13 17:56:57

Tags for this article:

Regulation of medical devices
Medical technology
Medical equipment
Food and Drug Administration
Pharmaceuticals policy
ISO 13485
ISO
Quality management system
Design controls
Medical device
Design history file
Quality management
u.s. food and drug administration

Click the tags to see associated articles and topics

View Article Details
4 Day Virtual Medical Device Software Compliance Course: Complying with the EU MDR ...

Added to Collection on: 2024-03-29 19:47:47

Tags for this article:

Regulation of medical devices
Medical device
Regulation (EU) 2017/745
IEC 62304
Regulation (EU) 2017/746
Notified body
Design controls
Validation
Postmarketing surveillance
Technical file
Software of unknown pedigree
Agile software development

Click the tags to see associated articles and topics

View Article Details
Major Areas of Cybersecurity Focus for Medical Device Makers - BankInfoSecurity

Added to Collection on: 2024-04-24 19:54:19

Tags for this article:

Food and Drug Administration
Cyberwarfare
Medical devices
Malware
Health care
Medical device
FDA Center for Devices and Radiological Health
Computer security
Cyber-security regulation
Design controls
Nastassia Tamari

Click the tags to see associated articles and topics

View Article Details
European Union: The impact of AI Act (EU Regulation 2024/1689) on legacy and in-house ...

Added to Collection on: 2024-11-02 17:21:46

Tags for this article:

Regulation of medical devices
Regulation (EU) 2017/745
Regulation (EU) 2017/746
Medical device
Medical Devices Directive
MDR
Notified body
SAMD
Regulation (EU) No. 305/2011
Directive (EU) 2021/555
Design controls
European Authorized Representative

Click the tags to see associated articles and topics

View Article Details
AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the ...

Added to Collection on: 2025-04-29 17:57:45

Tags for this article:

Regulation of medical devices
Regulation of artificial intelligence
Cybernetics
Existential risk from artificial general intelligence
AI safety
ISO 13485
Medical device
Artificial Intelligence Act
Artificial intelligence
Quality management system
Regulation (EU) 2017/745
Design controls

Click the tags to see associated articles and topics

View Article Details
FDA Expands Premarket Medical Device Cyber Guidance - BankInfoSecurity

Added to Collection on: 2025-06-27 20:25:17

Tags for this article:

Food and Drug Administration
Medical device
Federal Food, Drug, and Cosmetic Act
Computer security
Risk management
Design controls
FDA Center for Devices and Radiological Health
Medical device design
Kevin Fu

Click the tags to see associated articles and topics

View Article Details
Neuromod Regulatory Approvals to Improve Lenire Global Availability | The Hearing Review

Added to Collection on: 2025-10-01 03:38:25

Tags for this article:

Regulation of medical devices
Regulation (EU) 2017/745
Medical device
Tinnitus
ISO 13485
Food and Drug Administration
Regulation (EU) 2017/746
Regulatory compliance
Single Use Medical Device Reprocessing
Design controls

Click the tags to see associated articles and topics

View Article Details
Book a Demo