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 but you may publish an entire article or portions thereof on your website if Emergo Group is clearly credited as the author.
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
- Will Directive 2007-47-EC Change Your Approach to the Medical Devices Directive?
- Recast of the MDD
- Current state of CE Marking in Europe
- 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
DEVICE CLASSIFICATION
- When is software a medical device?
- Borderline products - consulting the manual
- Combination products: medical device, drug or both?
- Classification of cosmetic and aesthetic "devices"
- Are you considered a medical device manufacturer?
- Brief explanation of the Global Harmonization Task Force (GHTF)
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
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
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
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
RISK MANAGEMENT
- Medical Device Incident Reporting in Europe
- Medical Device Risk Management and Risk Analysis Using ISO 14971:2007
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
