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Searching Content by Jodi Scott from Hogan Lovells ordered by Published Date Descending.
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New FDA Draft Guidance On Voluntary Recalls Highlights Importance Of Recall Initiation Plans
On April 23, FDA issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C".
United States
27 May 2019
2
Your QMS Supports Your Global Operations And We Are Prepared To Support You
Satisfying ISO 134851 is important for U.S. and international medical device firms. Companies selling in the EU must operate their quality management systems (QMS) in compliance
United States
30 Apr 2019
3
Regulator Proposes Reducing Requirements For Radiation-Emitting Products
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products.
Belgium
26 Apr 2019
4
FDA Addresses Industry Feedback On Routine Inspections By Formalizing Processes And Standards In A Draft Guidance
On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection
Belgium
17 Apr 2019
5
3 Ways To Manage The Cyber Risk Posed By Connected Medical Devices
Connected medical technology is rapidly transforming patient treatment.
United States
8 Apr 2019
6
FDA Issues Final Guidance For Public Warnings And Notification Of Recalls
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings ...
United States
15 Mar 2019
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