Premium content to help you build better Medical Devices and get them to market faster

Building medtech is innovation… until documentation takes over.

Medical Device Design & Development Project

Medical device connectivity is becoming a core function of digital health.

Healthcare Cloud for Medical Connectivity

DHF, DMR, DHR, DDF, MDF...  It’s not just a list of acronyms.

Design record FDA vs ISO 13485

How AI became a reliable assistant for regulatory affairs, without replacing any human mind

AI + Human Workflow in QA/RA with Matrix Mind for Medtech

Clear Design Inputs are vital in medical device development under ISO 13485 or FDA regulations. Use the CUVC framework:

How to write excellent Design Input?

Regulatory expectations in MedTech are rising, with costs increasing by 50% for medical devices and 70% for IVDs. Documentation is now crucial for compliance, affecting timelines and team coordination.

The MedTech ToolBox

Your medical device can collect data. But can it transmit, analyze, and present it securely?

Medical Device Connectivity

Remote Patient Monitoring (RPM) is more than a data stream from a wearable.

The Future of Healthcare Remote Patient Monitoring

Did you design it right? Or did you design the right thing?

Design Verification & Validation

Each input becomes an output. Each output is verified against its input. It then becomes the input for the next step.

How to master Design Output?

How to Master Design Output?

Here is a practical guide to write your User needs & Requirements during design input

How to write your User Needs & Requirements

AI is a tool. The brain is still yours. Matrix Mind just helps you use it better.

How to use AI in Medtech

How to use IA in medtech

ISO 14971 says “manage risk.” But how do you analyze it?

Risk Analysis Techniques

Risk in Excel.  Requirements in Word.  Tests in SharePoint / dropbox.  Sound familiar?

Fix your Medical Device Design Documentation Workflow

From user needs to CE marking: why traceability isn't optional. In MedTech, every requirement must exist for a reason.

Medical Device Design & Development Strategy

Here are 12 practical tips for improving design control in MedTech product development.

12 Tips for Better Design Control

12 Tips for better Design Control

Not all software is equal. IEC 62304 defines 3 software safety classes based on risk of harm resulting from a hazardous situation.

Medical Device Software Safety Classification

Traceability connects ISO 14971 and IEC 62304.  Without it, risk control is incomplete. Risk management only becomes meaningful when each identified risk leads to a clear, implemented and verified control measure. ISO 14971 asks that every risk leads to a decision: reduce it, avoid it or accept it.

Software Risk Control Measures Implementation

Traceability isn’t just for the final review. It’s a daily tool for safer, smarter and compliant SaMD development.

Traceability in Medical Device Software Design

You have a CAPA process. But is it connected to your risk management & design controls?

Corrective actions & Preventive Actions

The ultimate cheat sheet of software design requirements

IEC 62304 - Medical Device Software - The Ultimate Cheat Sheet

IEC 62304 - Medical Device Software

Risk management is not complete without traceability. ISO 14971 is clear on risk management process

ISO 14971 - RISK MANAGEMENT

A high level overview of the software life cycle processes

IEC 62304 - Medical Device Software - Overview of the software life cycle processes

IEC 62304 - Medical Device Software -  overview of the software life cycle processes

Building medical device software? It's not just about IEC 62304.

Medical Device Software and Health Software

Considerations on the path to connecting a medical device to the cloud

The Definitive Guide to Medical Device Connectivity

The Definitive Guide to  Medical Device Connectivity

Completing design changes and maintaining a comprehensive design history file (DHF) are critical aspects of the Design Control process, particularly in ensuring that all modifications made during the lifecycle of a Medical Device are systematically documented and traceable.

Design Control in a Medical Device: A Complete Guide

The Definitive Guide to Medical Device Connectivity  Choosing the right toolset for Medical Device software development is essential for maintaining compliance, managing risks, and driving innovation.

Get your Medical Device software in market on any budget

Get your Medical Device software  in market on any budget

The Definitive Guide to Medical Device Connectivity  Creating and maintaining a comprehensive technical file for medical devices is essential for regulatory compliance and ensuring the safety and efficacy of the device.

Structure the technical file for your Medical Device

How to structure your technical file for your Medical Device

Our Application Lifecycle Management (ALM) Buyer’s Guide offers essential insights for choosing the best ALM tools and strategies tailored to your organization's needs.

Buyers Guide: Application Lifecycle Management (ALM)

Launch Medical Device in EU vs US

Buyers Guide Application Lifecycle Management

Comprehensive overview of Agile Metholody within medical devices, and how you can have R&D and Qualty teams collaborate.

Ultimate Guide to Bridging the Gap between R&D and Quality with your Medical Device

Bridging Gap Agile Compliance

Adhere to MDR guidelines effortlessly with our solutions. Ensure compliance and streamline processes for seamless regulatory adherence

Ultimate review of the MDR Guidelines Medical Device for market

Mastering EU MDR

Empower your software development lifecycle with our ALM solutions. Efficiently manage projects, streamline collaboration, and enhance overall productivity. 

What is Application Lifecycle Management (ALM)?

What is an Application Lifecycle Management System (ALM)?

Elevate quality and compliance with our QMS. Streamline processes, ensure regulatory adherence, and boost efficiency.

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