In the current issue...
- Reimbursement: Gerald Schnell and Jean-Philippe Benain
discuss five steps for designing an effective reimbursement strategy
for medical innovations in Europe
- QSIT/GMP: Sean Bundy and Carol Sammeth summarise how to
prepare for a US FDA QSIT/GMP inspection
- E-labelling: Kristen Giovanis looks at strategies and
tactics for preparing a company for electronic labelling
- Symbols: Gabriel Adusei reviews the symbols used in medical
device labelling and offers recommendations for emerging medical
technologies
- Clinical studies: Marija Capek provides an overview of the
requirements for pre- and post-market clinical studies with medical
devices in Europe
- Regulatory updates: Argentina, Australia, Brazil,
Canada, China, Denmark, European Union, Germany, International, Israel,
Italy, Japan, Kenya, Malaysia,
Mexico, Netherlands, New Zealand, Peru, Portugal, Saudi Arabia, South
Africa, Uganda, the UK,
the Ukraine and the USA plus environment and standards updates
- Country Overview: summary of the medical device regulatory
requirements in Japan
- Elemental Essentials: frequently asked questions on
European Directive 93/42/EEC, as amended
