MedTech Intelligence

Five Most Popular Articles of 2018 (So Far)

By MedTech Intelligence Staff

…Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and Revamp of the Medical Device Directive https://medtechintelligence.com/feature_article/new-eu-mdr-regulations-revamp-medical-device-directive/…

…Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and Revamp of the Medical Device Directive https://medtechintelligence.com/feature_article/new-eu-mdr-regulations-revamp-medical-device-directive/…

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Laura Johnson, Loftware
Soapbox

Emerging Trends and Opportunities in Medical Device Labeling

By Laura Johnson

European Commission’s (EU) Medical Device Regulation (MDR) recommendation this past year, and the implementation of similar processes in other regions and countries have helped put labeling front and center. Organizations…

European Commission’s (EU) Medical Device Regulation (MDR) recommendation this past year, and the implementation of similar processes in other regions and countries have helped put labeling front and center. Organizations…

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Brian Moan, Norman Rabin, Maetrics
Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin

After lengthy deliberation, agreement was finally reached over the new European Union In Vitro Diagnostic Medical Device Regulation (IVDR), which was approved by parliament on April 5, 2017 and published…

After lengthy deliberation, agreement was finally reached over the new European Union In Vitro Diagnostic Medical Device Regulation (IVDR), which was approved by parliament on April 5, 2017 and published…

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European Union Flag

The New MDR: Opportunity Knocks

By Peter Rose

The new Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5 last year. The regulation replaces both the previous Medical Device…

The new Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5 last year. The regulation replaces both the previous Medical Device…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Failure to Respond, Oh Boy

By Dr. Christopher Joseph Devine

…to see the regulatory can of whoop-ass about to be unleashed by the agency. Yes, there were multiple observations noted, five in all, plus a failure to establish an MDR

…to see the regulatory can of whoop-ass about to be unleashed by the agency. Yes, there were multiple observations noted, five in all, plus a failure to establish an MDR

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EU MDR Compliance

New EU MDR Regulations and Revamp of the Medical Device Directive

By Shilpa Gampa

…Identification of Notified Body for certification under New EU MDR Certification of new devices under New EU MDR Re-certification of existing devices and re-classified devices under New EU MDR Regulatory…

…Identification of Notified Body for certification under New EU MDR Certification of new devices under New EU MDR Re-certification of existing devices and re-classified devices under New EU MDR Regulatory…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Happy New Year and MDRs

By Dr. Christopher Joseph Devine

…migration in mass is occurring to the ISO 13485:2016 platform; EU 2017/745 (EU Medical Device Regulation) is now the law of many lands in the European Union; the final stages…

…migration in mass is occurring to the ISO 13485:2016 platform; EU 2017/745 (EU Medical Device Regulation) is now the law of many lands in the European Union; the final stages…

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Alert

Lack of Adequate CAPA Procedures Tops FDA’s List of Violations

By MedTech Intelligence Staff

…documented: 115 Nonconforming product; procedures not adequately established: 127 Lack of written MDR procedures: 127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls:…

…documented: 115 Nonconforming product; procedures not adequately established: 127 Lack of written MDR procedures: 127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls:…

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Checkbox

The Ultimate QA/RA Cheat Sheet

By Thomas Maeder

…reporters such as healthcare professionals, patients and consumers MDR Database – Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect…

…reporters such as healthcare professionals, patients and consumers MDR Database – Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect…

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