Each issue includes summaries in a number of European languages
| READ MORE |
| In English |
| Auf Deutsch |
| En Français |
| En Español |
In the current issue...
- Transparency: Rosina Robinson looks at the US FDA's transparency initiative
- Labelling: Donald Sherratt summarises the labelling requirements for medical devices in Asia
- Adverse events: Elisabethann Wright and Steven Datlof compare and contrast the adverse event reporting requirements in the EU and the USA
- Clinical evaluation: Haroon Atchia examines European MEDDEV 2.7.1 Rev 3
- Risk management: Mark Leimbeck and Larry Kessler review the market entry requirements for risk management, focusing on FDA and ISO 14971 compliance
- Regulatory updates: Australia, Canada, China, Czech Republic,
Egypt, Estonia, Europe, France, Greece, Hong Kong, India, Ireland, Italy, Japan, Korea,
Libya, New Zealand, Philippines, Singapore, Spain, Switzerland,
Tanzania, Uganda, the UK, the United Arab Emirates, and the USA plus the environment, standards and regulatory personnel on the move
- Country overview: the medical device regulatory requirements in
South Korea
- Elemental Essentials: REACH

