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MedTech Intelligence

Volume 13 Issue No. 14


FDAFDA Investigating More than 450 MDRs Related to Endoscope Reprocessing

By MedTech Intelligence Staff

The medical device reports describe both patient infections and other possible contamination issues.


Siemens - Modern and integrated manufacturing execution systems in medical devices

Featured Articles


Lessons Learned:
Medical Device Development through COVID-19 and Beyond

By Josh Turpen, Jama Software

It’s time to take stock on what temporary measures need to be made permanent to grow as an industry.

Data-Document Continuum:
Why Life Sciences Transformation Depends on Companies Overcoming
Information Silos

By MedTech Intelligence Staff

Companies within the life sciences industry should rethink how they manage their data and documents.


Geoff Wood, DNVAsk the Expert:
What Advantages Does a Pre-Assessment Offer?

A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit.


The Business Value of Cybersecurity in MedTechThe Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

Download now!

Patient Engagement and Connected Medical Devices:
Building the Next Generation of Wearable Devices to Enhance Remote Patient Care

By Adrian Pittman, Google; Bernhard Kappe and Randy Horton, Orthogonal

In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.


Regulatory Information Management Streamlines Processes and Supports Data Quality

By Romuald Braun, Amplexor

Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency.


EU IVDR - Process, Data, Reporting & PlanningEU IVDR - Process, Data, Reporting & Planning

March 30 - April 27, 2021

The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels.

Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market.

March 30, 2021: EU IVDR Introduction (On-Demand Recording)

April 6, 2021: Quality Processes and Documentation
(On-Demand Recording)

April 13, 2021: Clinical Evidence & Surveillance

April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling

April 27, 2021: Strategy and Planning

Details & Registration

MedTech Library

How to create scalable connectivity ecosystems for in-hospital medical equipmentHow to create scalable connectivity ecosystems for in-hospital medical equipment

Sponsored By S3 Connected Health

Connectivity is now a must when designing or redesigning in-hospital medical equipment.

Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment.

Download now!

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