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Francesco Palma
December 7, 2022
Francesco Palma
Ask the Engineer

Ask the Expert: EU MDR as a Trigger for Innovation

No Comments

EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.

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Mohamed Benkirane
September 21, 2022
Mohamed Benkirane
MEDdesign

Raising the Bar on Quality for MedTech Production

By Mohamed Benkirane
No Comments

Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.

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Compliance Process
April 13, 2022
Compliance Process

Change is the New Normal

By Huma.AI
No Comments

The only constant today is change itself.

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Risk Logic
April 6, 2022
Risk Logic

In Search of Flawless Devices

By Huma.AI
No Comments

Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).

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Loftware, PRISYM ID
January 13, 2022
Loftware, PRISYM ID

Loftware Acquires PRISYM ID, Expands Enterprise Labeling Solutions for Medical Device and Pharmaceutical Companies

By Loftware, Inc.
No Comments

Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform

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Robert Dostert, DNV
December 13, 2021
Robert Dostert, DNV

The EU Medical Device Regulation (MDR): What Lessons Have We Learned?

By Robert Dostert
No Comments

As more guidance is released, we can expect to see more agreement between competent authorities and notified bodies. Until this happens, there are still actions you can take to help eliminate the uncertainty.

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Robert Dostert, DNV
August 3, 2021
Robert Dostert, DNV

Ask the Expert: The EU Medical Device Regulation (MDR) – Is Anyone Ready and Where Are We Headed?

By Robert Dostert
No Comments

The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.

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James Thompson, Siemens
June 15, 2021
James Thompson, Siemens

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

By MedTech Intelligence Staff
No Comments

In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.

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Peter Willemse, Experlogix
May 6, 2021
Peter Willemse, Experlogix

Ask the Expert: How Can Medical Device Manufacturers Benefit from Configure, Price, Quote (CPQ) Software

By Experlogix, LLC
No Comments

A discussion with Peter Willemse about how configure, price, quote (CPQ) software can help medical device manufacturers deal with the nuances of everyday challenges and continue to drive revenue and increase profit margins.

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Geoff Wood, DNV
April 8, 2021
Geoff Wood, DNV

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

No Comments

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

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