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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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ISO 13485:2016 - Medical Device Quality Management Systems
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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What MUST be signed and dated? FDA QSR requires signatures for specific sections
Monica Lewis
Feb 1, 1999
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Design Control SOP - Streamlining with R&D Department
kennethmabou
Jan 26, 2012
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6
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Jan 27, 2012
sagai
M
Problems implementing ISO 13485 for Software-Only Medical Device Manufacturers?
Marcelo
Jan 22, 2012
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4
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Jan 26, 2012
Marcelo
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Class IIa Medical Device - Can I over label to change an address?
J1980b
Jan 25, 2012
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pkost
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Non Conformance Closure by including it on another Corrective Action
Quality Priest
Jan 25, 2012
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Jan 25, 2012
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Breast Implant Scandal in France - Industrial Silicone Used in Implants
Gert Sorensen
Jan 2, 2012
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Jan 24, 2012
Ronen E
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ISO 13485 x ICH Q10 Pharmaceutical Quality System - Comparison Evaluation
Marcelo
Jan 22, 2012
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2
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4K
Jan 23, 2012
Marcelo
M
N
Sterilisation of IV Bags used for Veterinary Blood Plasma Products
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Jan 17, 2012
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7
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Jan 23, 2012
Ronen E
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Nonconforming Implantable Dental Devices
JanWarner
Jan 19, 2012
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Jan 20, 2012
JanWarner
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Unscheduled Maintenance - Product Impact when a machine goes down
stonehouse10
Dec 10, 2009
2
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16
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Jan 20, 2012
DrM2u
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Refurbisher (re-loader) of OEM X-Ray Tubes - Marketing to Canada
blmuskrat
Jan 19, 2012
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Jan 20, 2012
Stijloor
P
Single Use Devices - Surgeon must have backup in stock, just in case?
peter_traina
Nov 15, 2011
2
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17
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5K
Jan 17, 2012
Ronen E
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ISO 13485 & FDA Requirements - What kinds of software require validation?
Fralem
Jan 11, 2012
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2
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7K
Jan 11, 2012
sagai
Q
Where to buy the ISO 13485 standard in a pocket sized book
QA Systems Manager
Jul 30, 2010
2
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19
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10K
Jan 9, 2012
Mikishots
FDA Guidance for Biomarker Qualification Studies
Michael Malis
Jan 9, 2012
Replies
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Jan 9, 2012
Michael Malis
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