Medical Device Blog

/Medical Device Blog
Medical Device Blog 2018-02-16T13:10:26+00:00

MEDICAL DEVICES

FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…

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  • FDA Sent These Warning Letters

FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

January 31st, 2018|0 Comments

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]

If You Didn’t Document It, It Didn’t Happen

January 25th, 2018|0 Comments

A Guest Post from Oliver Yu, CTO, FDAzilla A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company.  The drug and the documentation proving that the [...]

  • US-EU Mutual Recognition Agreement of 2017

US-EU Mutual Recognition Agreement of 2017

August 22nd, 2017|0 Comments

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the [...]