DHF vs DMR: Breaking Down the Key Components of Medical Device Documentation

by Jeremy Moore | Dec 17, 2024 | Compliance and Regulatory Guidance, Product Development

DHF vs DMR—Why Knowing the Difference MattersWhat is a DHF? Understanding the Design History FileKey Elements of a DHFWhat is a DMR? The Role of the Device Master RecordKey Elements of a DMRDHF vs DMR: Key Differences and How They Work TogetherPurpose: Development vs....

IQ, OQ, PQ Validation for Medical Devices: A Quick Reference Guide for Medical Device Validation

by Jeremy Moore | Nov 26, 2024 | Product Development

Why IQ, OQ, PQ Validation for Medical Devices MatterWhat is IQ, OQ, PQ Validation for Medical Devices?Step-by-Step: How to Approach Each Validation StageInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Avoiding Common Pitfalls...

8 Key SaMD Development Challenges—and How to Overcome Them

by Jeremy Moore | Oct 16, 2024 | Software as a Medical Device, Product Development

Navigating the Complexities of SaMD Development ChallengesSaMD Development Challenge 1: Regulatory Compliance and Navigating Changing RegulationsSaMD Development Challenge 2: Ensuring Patient Safety and Risk ManagementSaMD Development Challenge 3: Aligning with...

Lean Product Development for Medical Devices: Accelerating Innovation and Reducing Costs

by Jeremy Moore | Aug 15, 2024 | Product Development

Streamlining Medical Device Manufacturing with Lean Product DevelopmentWhat is Lean Product Development for Medical Devices?Origins of Lean MethodologyRelevance to Medical DevicesKey Principles of Lean Product Development for Medical DevicesValueValue Stream...

Choosing the Right Path: 510(k) vs De Novo Pathways for SaMD

by Jeremy Moore | Jul 19, 2024 | Software as a Medical Device, Compliance and Regulatory Guidance, Product Development

Unlocking Regulatory Success: 510(k) vs De Novo Pathways for SaMDUnderstanding the 510(k) PathwayDefinition and Background of the 510(k) Pathway:Requirements of the 510(k) Pathway:Process for the 510(k) Pathway:Advantages of the 510(k) Pathway:Limitations of the...

Why Do We Need Risk Management for Medical Devices: How Risk Management Can Add Value and Reduce Risk

by Jeremy Moore | Jul 12, 2024 | Product Development, Compliance and Regulatory Guidance

Why Risk Management is a Game-Changer for Medical DevicesUnderstanding Risk ManagementWhat is Risk Management for Medical Devices?Why is Risk Management Crucial in the Medical Device Industry?Key Components of Risk Management for Medical DevicesRisk Identification:...