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FDA
January 5, 2022
FDA

One Death, Six Complaints: Covidien Recalls Puritan Ventilators Due to Manufacturing Error

By MedTech Intelligence Staff

A capacitor manufacturing assembly error could cause the device to become inoperable.

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magnifying glass
December 2, 2021
magnifying glass

Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices

EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.

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Columns

November 17, 2025

Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance

By Holger Wagner
Aligning MedTech Compliance

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new benchmarks.

September 26, 2025

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

By MedTech Intelligence Staff, Rene Zoelfl
Product Lifecycle Management

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

August 17, 2025

Why Your Regulatory Compliance Strategies Aren’t Keeping Pace

By Caroline DeTore

Over the past decade, global regulations for medical technology have skyrocketed from around 500 to over 8000. Navigating the complexities of regulatory compliance is a daunting task—especially when faced with orthogonal aspects of regulations.

August 17, 2025

Streamlining Compliance for Quicker MedTech Market Entry

By Manuela Kohlhas
MedTech Compliance Process

As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with non-compliance

April 18, 2025

The Agile MedTech Lifecycle: Rethinking Regulatory Adoption in a Time of Global Disruption

By Arjunvasan Ambigapathy

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

January 2, 2025

CMMS Software: Enhancing Regulatory Compliance

By Donal Bourke

Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements.

December 13, 2024

Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

Overcoming 21 CFR compliance challenges - stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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