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....

Quick Guide to Medical Device Standards: Key Regulations and How to Navigate Them

by Jeremy Moore | Dec 11, 2024 | Compliance and Regulatory Guidance

Why Medical Device Standards MatterWhat Are Medical Device Standards?Definition and PurposeBenefits of ComplianceDifferent Types of StandardsKey International Standards You Need to KnowISO 13485: Quality Management System for Medical DevicesISO 14971: Risk Management...

Complete ISO 13485 Guide for Medical Device Companies

by Jeremy Moore | Dec 5, 2024 | Compliance and Regulatory Guidance

Your Complete ISO 13485 Guide: Why it Matters in Medical DevicesWhat is ISO 13485? A Quick OverviewCore Requirements of ISO 13485Steps to Achieving ISO 13485 CertificationBenefits of ISO 13485 Certification for Medical Device CompaniesMaintaining Compliance: ISO 13485...

ISO 13485 Internal Audit Checklist: Ensuring Quality Compliance for Medical Devices

by Jeremy Moore | Nov 19, 2024 | Compliance and Regulatory Guidance

Why Every Company Needs an ISO 13485 Internal Audit Checklist for ComplianceWhy Internal Audits Are Critical in ISO 13485 ComplianceKey Components of an ISO 13485 Internal Audit1. Audit Scope2. Audit Frequency3. Audit Planning4. Audit Execution5. Audit ReportingISO...

ISO 13485 vs ISO 9001: What’s the Difference and Why It Matters for Medical Device Companies

by Jeremy Moore | Oct 30, 2024 | Compliance and Regulatory Guidance

Choosing the Wrong Standard Could Shut Down Your ProductWhat is ISO 13485?What is ISO 9001? (Focus on General Quality Management)ISO 13485 vs ISO 9001: Core Differences1. Industry Focus:2. Regulatory Requirements:3. Risk Management:4. Customer vs. Regulatory Focus:Can...

Navigating the 510(k) Submission Process: Your Step-by-Step Guide to FDA Clearance

by Jeremy Moore | Oct 2, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

The 510(k) Submission Process: A Critical Pathway to FDA ClearanceUnderstanding the 510(k) Pathway: What Is It and Who Needs It?Types of 510(k) Submission Process and When to Use ThemThe Step-by-Step 510(k) Submission ProcessTips for a Smooth 510(k) Submission...