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FDA Alert: Baxter Recalls Spectrum Infusion Pumps

by Devices and Pharma | Jul 4, 2025 | Alerts, Alerts-Device, Class I Recalls, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Baxter Recalls Spectrum Infusion Pumps Software error could result in dangerous dosing Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Baxter Spectrum Infusion Pump Alert Date: July...

Orthopedics Industry Consolidation

by Devices and Pharma | May 18, 2025 | Implantable Devices, Industry Information, Industry News, Orthopedics

Orthopedic Device Industry Consolidation Combining company assets Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Consolidation in the Implantable Orthopedics Industry: A Historical Perspective ...

QMSR Clause 6 – Resource Management

by Devices and Pharma | Apr 29, 2025 | Industry News, ISO 13485, Med-Devices, QMSR, QSR, QSR-to-QMSR, Quality system, Resource Management

QMSR Clause 6 - Resource Management The transition from QSR to QMSR Home QMSR Central Transition Definitions Regulations Small Manufacturers Ensuring the Organization Has the Capability to Deliver Safe and Effective Medical Devices Clause 6 of ISO 13485:2016 defines...

QMSR Management Responsibility

by Devices and Pharma | Feb 21, 2025 | Industry News, ISO 13485, Med-Devices, QMSR, QSR, QSR-to-QMSR, Quality system

Management Responsibility QMSR requirements Home QMSR Central Transition Definitions Regulations Small Manufacturers QMSR Management Responsibility The QMSR Management Responsibility requirements bring a more structured, documented, and proactive approach compared to...

QMSR Clauses 1 and 2 – Scope and Normative References

by Devices and Pharma | Feb 19, 2025 | Industry News, ISO 13485, QMSR, QSR, QSR-to-QMSR, Quality system, References

QMSR ISO 13485 Clauses 1 and 2 Scope and Normative References Home QMSR Central Transition Definitions Regulations Small Manufacturers ISO 13485 Clause 1 and Clause 2 For medical device manufacturers, compliance with ISO 13485:2016 is essential to ensure the quality,...

QMSR Design and Development Transfer and Changes

by Devices and Pharma | Feb 18, 2025 | Design Changes, Design Transfer, Industry News, ISO 13485, Med-Devices, Product Quality, QMSR, QSR, Quality Information, Quality system

QMSR Design and Development Controls Design Transfer and Changes Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers ISO 13485:2016 Design and Development Clause 7.3 - Design and...
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