Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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7D Surgical’s Cranial Module Device Receives FDA Approval
The device can register multiple datasets to visualize the patient’s anatomy using many types of medical imaging.
NICE Reverses Decision to Reject Besponsa
The institute said that the medicine could be an important treatment option for individuals with ALL and is generally well tolerated.
Postmarket Safety
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