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Resources
Blog
24/6/26
Case study
8/13/26
Electrosurgical device company needing technically diverse CDMO partners with Meddux to help drive product development to manufacturing transfer.
White Paper
10/10/25
A validated computational model that predicts how a laser-cut hypotube will bend and stretch — before the first prototype is cut.
6 June 2024
How the concept phase sets technical requirements and de-risks a device program early.
A Pragmatic Approach to Quality
09 Sep 2024
Meeting regulatory requirements for a QMS without letting quality standards slip.
User-Centered Design
08 Aug 2024
How use-related risk fits into UCD: frameworks, common gaps, and practices that hold.
Identifying, assessing, and mitigating risk across the whole development lifecycle.
Energy Therapeutics
24 Jun 2026
Design considerations for RF, pulsed field, microwave, and ultrasound delivery systems.
Innovation in Healthcare
12 Sep 2025
How analysis and synthesis turn analogies from other industries into new concepts.
CDMO Model
05 Jun 2025
The advantages of a CDMO partner from early design through to commercial launch.
03 Nov 2025
A practical guide to PPQ: validation, critical parameters, statistics, best practices.
12 Dec 2025
Design firm, D&D, CMO, or CDMO: how to choose the right partner for your device stage.
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27 Feb 2026
When to switch manufacturing partners, and how to bring down your total cost of quality.
How prototypes, from paper sketches to functional builds, surface use problems early.
What an effective QMS needs: compliance, risk management, and improvement that holds.
22 Apr 2026
Why HF/UE is more than FDA compliance: usability that drives adoption and market reach.
Aligning user-centered design with IEC 62366 and FDA human factors expectations early.
A medical device QMS from zero: compliance, risk management, and supplier oversight.
18 May 2026
Balancing control, flexibility, and manufacturability in steerable catheter design.
Design thinking is a strong start, not a full process. Where it breaks and what fixes it.
cAse study
August 13, 2026
Multinational medical device firm partnered with Meddux to rapidly prototype and refine an innovative cardiology instrument, confirming design feasibility.
An energy therapeutics company partners with Meddux to design, develop, and manufacture its soft tissue ablation catheter.
Medical device company partners with Meddux to execute design controls, validate critical processes, and establish scalable cleanroom manufacturing for FDA-registered commercialization.
Global medical technology OEM contracts Meddux to conduct manufacturing analysis and apply critical parameter management approach for product quality optimization.
A biotechnology company focused on developing DNA-based therapeutics partners with Meddux to develop a delivery system for First-In-Human Clinical Trials.
Startup company contracts Meddux to develop novel neurovascular catheter with integrated energy therapy delivery.
August 9, 2026
A startup contracts Meddux to accelerate an innovative radiofrequency ablation (RFA) therapy from concept to clinical trial.
white paper
October 10, 2025
July 22, 2024
A structured path from initial concept to manufacturing excellence in a highly regulated environment.
August 19, 2024
How user-centered design shapes medical device development — from intuitive, safe devices to design controls and compliance.
A joint study with MSI comparing CathCAD-predicted and empirical catheter performance, and how braid pattern affects both performance and manufacturing cost.
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