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QSR to QMSR: FDA Gives Medical Device Makers Two Years to Comply with New Quality Regulations

QSR to QMSR: FDA Gives Medical Device Makers Two Years to Comply with New Quality Regulations

by ptlsolut | Apr 25, 2024 | Quality Management Systems

Properly timing compliance with QMS Document and Version Controls

Properly timing compliance with QMS Document and Version Controls

by ptlsolut | Aug 22, 2022 | Quality Management Systems

In our first article discussing timing in the context of designing a new medical device, we discussed the technical feasibility process (TFP), or the stage in which medical device concepts are designed prior to the initiation of the formal design control process. The...
Properly timing compliance with QMS Purchasing Controls and Acceptance Activities

Properly timing compliance with QMS Purchasing Controls and Acceptance Activities

by ptlsolut | Jun 13, 2022 | Quality Management Systems

In our first article discussing “timing” in the context of designing a new medical device, we discussed the technical feasibility process (TFP), or the stage in which medical device concepts are designed and matured prior to the initiation of the formal design control...

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