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Compliance Process
April 13, 2022
Compliance Process

Change is the New Normal

By Huma.AI

The only constant today is change itself.

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Etienne Nichols, Greenlight Guru
March 24, 2022
Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

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Mark Quinlan, UPS
November 12, 2015
Mark Quinlan, UPS

Embrace Regulations, Improve Patients’ Lives

A Q&A on how device companies can respond to supply chain risks and regulations.

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Columns

April 30, 2026

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

By Lavanya Ramnath, Srividya Narayanan
Toddler Wearable Health Devices and Monitors

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.

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 30, 2025

4 FAQs to Notified Bodies

By Kevin Holochwost
medtech design standards

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

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 7, 2025

Enlil Announces 7 Strategic Partnerships to Accelerate MedTech Innovation and Customer FDA Clearance Success

Enlil logo

Press Release: New partnerships mark a significant step forward in expanding the MedTech industry’s adoption of Enlil’s agentic AI-assisted development traceability platform. By aligning with leaders in regulatory consulting and innovation support, Enlil enhances both its service reach and sharpens its ability to deliver end-to-end traceability, faster implementation timelines, and deeper integration across the product development lifecycle.

June 6, 2025

Japan Reimbursement (Part 1): What do you need to know about getting your medical device reimbursed in Japan?

By Ames Gross

Medical Devices must be fully reimbursable – no out of pocket expenses – in Japan. So, how is reimbursement achieved for your medical device?  

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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