Medical Device QA & RA Articles Written By Emergo Group

These articles on medical device quality assurance or regulatory compliance issues have been written by Emergo Group. All articles are copyrighted by Emergo Group.

CE MARKING

• Who needs CE Marking? A Primer for Medical Device Manufacturers
• Directive 2007/47/EC - Changes it Makes to the Medical Devices Directive 93/42/EEC
• The Declaration of Conformity - A Declaration of What to Whom?
• Regulations for Medical Devices and the Role of Guidance Documents in Europe
• Choosing an EU Authorised Representative for Medical Device Regulatory Issues
• CE Marking Conformity Assessment Options for Medical Device Companies
• EU CE Mark: An Overview for Medical Device Companies on CE in Europe
• New Year, New Details of European Regulatory Changes Ahead (2012)

FDA 510(k) APPROVAL (CLEARANCE)

• The Steps in the FDA 510(k) Clearance Process
• Six Mistakes Sure to Delay Your FDA 510k Review

DEVICE CLASSIFICATION

• When is Software a Medical Device?
• Borderline Products - Consulting the Manual
• Classification Borderline: What Constitutes a Medical Device?
• When is a Device Not a Device?
• Combination Products: Medical Device, Drug or Both?
• Classification of Cosmetic and Aesthetic "devices"
• Medical Device Kits: System and Procedure Packs
• Are You Considered a Medical Device Manufacturer?
• European CE Declaration of Conformity for Medical Devices

DISTRIBUTION

• Finding and Selecting Medical Device and Surgical Distributors in Europe
• You Have Found Distributors for Your Device in Europe. Now What?

LABELING AND TRANSLATION

• Overview of Medical Device Labeling
• Medical Device IFU and Documentation Translation
• EN 980:2008 and Medical Device Labeling
• Phthalate Labeling Requirements for Medical Devices
• e-Labeling: Instructions for Use (IFU) in Electronic Format

MISCELLANEOUS

• Brief Explanation of US FDA Export Certificates
• The European General Product Safety, Product Liability & Product Warranty Directives
• Green Dot & Packaging Waste Directive Compliance in Europe
• The Packaging Waste Directive: What it Means for IVD/Medical Device Manufacturers
• Updates on the European General Product Safety Directive
• Surveillance of Packaging Waste in Europe
• Revisions to the European New Approach Directives
• WEEE Directive and Green Dot in Europe
• Are European Bar Code Requirements on the Horizon?
• Do You Need To Register With The FDA?

QUALITY SYSTEM COMPLIANCE

• How to Select a Notified Body for Europe
• Switching From One EU Notified Body to Another
• Reasons Companies Change their Notified Body
• Overview of ISO 13485 and Other Standards that Apply to the Medical Device Industry
• Auditing the Quality Management System of Suppliers and Subcontractors
• Common Audit Problems and How to Deal with Them
• FDA Audit Checklist - Preparing for an FDA Auditor Visit
• FDA cGMP Compliance: An Overview of cGMP Quality System Compliance for Medical Device Manufacturers

REGULATORY SUBMISSIONS

• Technical Files, An Overview of Content and Format
• A Detailed Look at the Medical Device Approval Process in Russia
• Overview of Mexico's Medical Device Registration Process
• Update on Medical Device Registration in Italy
• Outsourcing Regulatory Functions

RISK MANAGEMENT

• Medical Device Incident Reporting in Europe
• Medical Device Risk Management and Risk Analysis Using ISO 14971:2007
• Medical Device Clinical Evidence Requirements

SURVEILLANCE & VIGILANCE

• Implementing a Medical Device Post-Market Surveillance Program
• Medical Device Vigilance and Guidance 2.12.1 rev 5 Explained
• Medical Device Post-Market Surveillance and Vigilance
• Capitalize on Post-Marketing Surveillance Data
• Importance of Vigilance in the EU
• Eudamed and Global Medical Device Nomenclature (GMDN)