James Thompson, Siemens

Ask the Expert: Leveraging the Digital Infrastructure to Align with Best Practices and Accelerate Growth

By MedTech Intelligence Staff

…life-saving products to patients who need them. MedTech Intelligence: What is the Siemens answer to the FDA – Case for Quality program and the new EU MDR requirements? Thompson: Siemens…

…life-saving products to patients who need them. MedTech Intelligence: What is the Siemens answer to the FDA – Case for Quality program and the new EU MDR requirements? Thompson: Siemens…

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Barry O'Sullivan
Soapbox

The MDR and Opportunities for MedTech

By Barry O’Sullivan

The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector….

The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector….

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Medtech, innovation

AI in MedTech: Risks and Opportunities of Innovative Technologies in Medical Applications

By Dr. Abtin Rad

…the European Parliament and of the Council of 5 April 2017 on medical devices https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745. Last accessed 16 Nov 2020 Banko, M. and Brill, E. 2001. Scaling to very very…

…the European Parliament and of the Council of 5 April 2017 on medical devices https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32017R0745. Last accessed 16 Nov 2020 Banko, M. and Brill, E. 2001. Scaling to very very…

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Jon Speer, Greenlight Guru
Soapbox

What Are the Biggest Changes under EU MDR?

By Jon Speer

The compliance deadline for the new EU MDR is right around the corner. With new regulations come new processes affecting medical device companies. Time is of the essence with nearly…

The compliance deadline for the new EU MDR is right around the corner. With new regulations come new processes affecting medical device companies. Time is of the essence with nearly…

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Geoff Wood, DNV

Ask the Expert: What Advantages Does a Pre-Assessment Offer?

…(i.e. ISO 13485:2016, MDR, or MDSAP) and are new to MD manufacturing, benefit greatly. Typically, these manufacturers are established in other markets such as aerospace, semiconductor, or automotive and already…

…(i.e. ISO 13485:2016, MDR, or MDSAP) and are new to MD manufacturing, benefit greatly. Typically, these manufacturers are established in other markets such as aerospace, semiconductor, or automotive and already…

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FDA

FDA Investigating More than 450 MDRs Related to Endoscope Reprocessing

By MedTech Intelligence Staff

Proper reprocessing of urological endoscopes is once again in the spotlight, as FDA announced that it is investigating medical device reports (MDR) that cite patient infections and contamination issues linked…

Proper reprocessing of urological endoscopes is once again in the spotlight, as FDA announced that it is investigating medical device reports (MDR) that cite patient infections and contamination issues linked…

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Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne

Manufacturers around the world are preparing for the upcoming implementation of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulations. For medical device and diagnostics…

Manufacturers around the world are preparing for the upcoming implementation of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulations. For medical device and diagnostics…

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Romuald Braun, Amplexor
Soapbox

Regulatory Information Management Streamlines Processes and Supports Data Quality

By Romuald Braun

…quality. In the European Union, IDMP data-based marketing authorization submissions are compulsory as of January 2021 for centralized procedures, and the new EU MDR will fully apply in EU Member…

…quality. In the European Union, IDMP data-based marketing authorization submissions are compulsory as of January 2021 for centralized procedures, and the new EU MDR will fully apply in EU Member…

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