by Jeremy Moore | Mar 5, 2025 | Product Development, Software as a Medical Device
Overcoming SaMD Development Challenges: What’s Standing in Your Way?Challenge #1: Navigating Complex Regulatory RequirementsChallenge #2: Managing Software Development Under a QMSChallenge #3: Ensuring Cybersecurity & Patient Data ProtectionChallenge #4:...
by Jeremy Moore | Feb 5, 2025 | Product Development, Compliance and Regulatory Guidance
Why Biocompatibility in Medical Device Design MattersWhat Is Biocompatibility in Medical Device Design—and Why Does It Matter?Understanding ISO 10993 and Its Role in Biocompatibility for Medical Device DesignHow to Integrate Biocompatibility In Medical Device...
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....
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...
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...
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...
