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. If you are interested in republishing these articles (or portions thereof) on your website, please contact us.
Implementing a medical device post-market surveillance program
Article focuses on how companies can identify, implement and administer an effective risk-management process (including post-market surveillance and vigilance) that is compliant with ISO 14971:2007.
The European General Product Safety, Product Liability & Product Warranty Directives
Discussion of three other directives designed to protect consumers and users in Europe: General Product Safety Directive, Product Liability Directive and the Product Warranty Directive.
Finding and selecting medical device and surgical distributors in Europe
Article that discusses how to go about finding, qualifying, selecting and managing medical device distributors in Europe.
You have found distributors for your device in Europe. Now what?
Article discusses the next step after you have found distributors for your medical devices. Covers contracts, payments, documentation, shipping, duties, VAT, returns, servicing and more.
Directive 2007-47-EC - Changes it makes to the Medical Devices Directive 93-42-EEC
Article summarizes the major changes to the European Medical Device Directive (93/42/EEC) as amended by Directive 2007/47/EC.
Medical Device IFU and Documentation Translation
Article talks about what documents must be translated, the rules for translation, use of symbols and risks associated with not doing translations.
Medical Device Incident Reporting in Europe (Part 1)
First in a two part article that d iscusses when medical device and IVD manufacturers should report inclidents involving their devices as specified in the Medical Devices Directive (93/42/EEC).
How to select a Notified Body for Europe
Read more about how you should research, analyze and choose a Notified Body for Europe.
Regulations for Medical Devices and the Role of Guidance Documents in Europe
Have you ever wondered how 27 countries in Europe cooperate to regulate medical devices? This article explains the process of continental cooperation.
Medical Device Vigilance and Guidance 2.12.1 rev 5 Explained
This informative article unravels the newest vigilance guidance document 2.12.1 rev 5 and the impact it has on medical device companies.
When is software a medical device?
Software is a component of many medical devices or acts as an independent medical device. This article discusses the gray areas of when software should be regulated as a device.
Medical Device Risk Management and Risk Analysis Using ISO 14971:2007
This article discusses ISO 14971:2007 and its application to medical device and IVD manufacturers.
Are you considered a medical device manufacturer?
This article defines and explains the different types of medical device manufacturers, categorized by how they conduct their operations.
Combination products: medical device, drug or both?
Combination products are products that share the attributes of two categories of products. This article discusses the particular combinations of medical devices and medicinal products.
EU Medical Device Directive Revisions and How Those Changes May Affect You
The long-anticipated revisions to the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) were published in Directive 2007/47/EC.
State of CE Marking in Europe
Article discusses whether the European Union is continuing to progress in into one internal market, or reverting into individual national states with their own national laws and requirements.
Who needs the CE Mark and CE certification? A primer for medical device manufacturers
Europe is easier to access than ever before, yet, many North American exporters, especially small and medium sized enterprises, avoid it because the regulatory requirements for entry seem too complicated.
Medical Device Post-Market Surveillance and Vigilance
Article discusses post-market surveillance and vigilance of medical devices.
Green Dot & Packaging Waste Directive Compliance in Europe
Article discusses the Packaging Waste Directive in Europe and the Green Dot program for compliance.
The Packaging Waste Directive: What it Means for IVD/Medical Device Manufacturers
Updates on the European General Product Safety Directive
The General Product Safety Directive was developed to establish safety requirements for consumer products not regulated by sector legislation (the way medical devices or machinery are).
Medical Device Clinical Evidence Requirements: Are You Prepared?
Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.
Emergo expands, adds 7 new employees
Reflecting a booming market for manufacturers of medical devices, Emergo Group, Inc. recently hired 7 new employees to accommodate increased demand from North American companies.
How to select a European Notified Body
Article discusses how medical device and IVD companies should evaluate and select a Notified Body for their ISO certification and ongoing audits.
What are your quality standards?
Hundreds of companies approach us each year in their quest to obtain the CE Mark for their medical device. Sometimes those "companies" consist of nothing more than one person making a device in his or her garage.
The Packaging Waste Directive: What it means for IVD/medical device manufactures
Many of the early European Union packaging waste regulations did not establish the link between waste management and the environment.
Choosing an EU Authorised Representative for Medical Device Regulatory Issues
So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, marketing, shipping, and distributing your medical devices. But wait, a host of regulatory issues still loom.
Do you need an FDA Export Certificate?
An export certificate is a document prepared by the FDA that contains information about a product's regulatory status. It's an extra measure of assurance that your product meets FDA requirements in the United States.
What is the GHTF?
The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry.
Surveillance of Packaging Waste in Europe
The appropriate European Union authorities are becoming more vigilant in their desire to increase and improve surveillance regarding the Packaging and Packaging Waste Directive (94/62/EC) within the EU member states.
Auditing the Quality Management System of Suppliers and Subcontractors
According to MDD Annex II, item 3.3, Annex V, 3.3 and Annex VI, 3.3 or IVDD Annex IV, item 3.3 and Annex VII, item 3.3 an inspection on the premises of the manufacturer's subcontractor will take place in duly substantiated cases.
