Monthly Archives: December 2016

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Julie Larsen Receives Association of Food and Drug Officials (AFDO) Award

Julie Larsen Receives the Association of Food and Drug Officials (AFDO) Associate Member Award International Honor for Exemplary Success and Leadership in Drug & Medical Device Safety Please be assured that in the event of further disruptions, we are prepared to continue with our services remotely in a secure environment [...]

By |2021-02-12T02:55:11+00:00December 29th, 2016|News, Press Releases|0 Comments

Medical Device Cyber Risk Management

Medical Device Cyber Risk Management Armin Torres, Principal, Qualified Data Systems, a BioTeknica sister company. Medical Device Cyber Risk Management is the marriage between Safety and Security. It may seem an afterthought that we should be innately capable of living on a safe and secure planet as humans, but what about the connected devices [...]

By |2021-02-12T02:56:54+00:00December 29th, 2016|Blog, S3 Compliance Matters|0 Comments

Inspection Data and Areas of Emerging Concern

Inspection Data and Areas of Emerging Concern CDRH Publishes 2015 Annual Medical Device Quality System Data Reviewing and understanding the latest data on inspections, inspectional observations, and Warning Letter citations is critical for life science manufacturers. In support of the FDA’s transparency and Case for Quality initiatives, FDA’s Center for Devices and Radiologic [...]

By |2021-02-12T02:59:12+00:00December 29th, 2016|Blog, S3 Compliance Matters|0 Comments
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