by Jeremy Moore | Aug 27, 2024 | Compliance and Regulatory Guidance, Quality Management
Understanding the CAPA Process for Medical Devices: Your Path to Compliance and QualityWhat is the CAPA process for Medical Devices? Defining CAPA:The Role of CAPA in the Medical Device Industry:Regulatory Requirements:Why the CAPA Process for Medical Devices is...
by Jeremy Moore | Aug 20, 2024 | Software as a Medical Device
Streamlining Medical Device Manufacturing with Lean Product DevelopmentThe Transformative Potential of AI in SaMDKey OpportunitiesConsiderations and ChallengesData Privacy and Security Regulatory Compliance Ethical Concerns Technical and Infrastructure Challenges Loss...
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...
by Jeremy Moore | Aug 7, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
Introduction to FDA Pre-Submission MeetingsUnderstanding FDA Pre-Submission MeetingsCommon Pitfalls in FDA Pre-Submission Meetings1. Lack of Preparation2. Inadequate Data or Documentation3. Miscommunication or Lack of Clarity4. Not Defining Objectives Clearly5....
by Jeremy Moore | Jul 30, 2024 | Quality Management
Introduction to the Core Elements of a Quality Management System (QMS)Understanding a Quality Management System (QMS)Definition: What is a Quality Management System?Importance: Why is a Quality Management System Crucial for Medical Device Companies?Scope: Industries...
