Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
June 23, 2020
3
min read
New Unique Device Identifier Deadline Approaches
New Unique Device Identifier Deadline Approaches
May 12, 2020
2
min read
New FDA Guidelines Affect Labeling Consideration for Intravascular Devices with Lubricious Coatings
New FDA Guidelines Affect Labeling Consideration for Intravascular Devices with Lubricious Coatings
May 6, 2020
2
min read
Virtual Audit Planning
Virtual Audit Planning
April 10, 2020
2
min read
FDA Refuse-to-Accept (RTA) Guidance
FDA Refuse-to-Accept (RTA) Guidance
April 5, 2020
2
min read
FDA Updates Special 510(k) Guidance
FDA Updates Special 510(k) Guidance
March 12, 2020
1
min read
Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting
Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting
February 3, 2020
2
min read
Medical Device Risk Management: An ISO14971 Update
Medical Device Risk Management: An ISO14971 Update
December 23, 2019
3
min read
Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes
Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes
November 19, 2019
3
min read