Knowing the core of Design Transfer
Design Transfer is a key concept in transferring the device design from development to manufacturing. But what should a person in charge of the Design… Read More »Knowing the core of Design Transfer
Design Transfer is a key concept in transferring the device design from development to manufacturing. But what should a person in charge of the Design… Read More »Knowing the core of Design Transfer
The submission routes for Combination Products can be overwhelming. Read here the hack to the submission routes with the FDA for Drug-/Device-/Biologics Combination Products. the… Read More »FDA Combination Product submission routes
CE-mark, the European sign of conformity, is something that is adulterated sometimes. But how to identify a correct CE mark? Read the unique identification specifics… Read More »How to identify a correct CE-mark
Ever wondered what the differences between the consultation procedure and the Notified Body opinion is or are you confused on the terms? Then read on…… Read More »The difference between Consultation Procedure and Notified Body Opinion
Avanti Europe AG turns 5 years and we are thankful for the continuous support and partnership of our clients and the efforts of our team.… Read More »Avanti Europe turns 5
You might have come across the terms electronic Quality Management System (eQMS) and electronic Document Management System (eDMS). But what exactly is the difference between… Read More »What is the difference between eQMS and eDMS
Over the last weekend, 5 Standards have changed, 1 Guideline has been updated and 1 Regulation has come into force. Well, even though these change-rate… Read More »Regulatory Monitoring explained
Product Claims on the label are an important way to communicate the different aspects of the product and its use. But what if the claims… Read More »Your guide to bullet-proof claims
Data mining – which has evolved from a buzz-word to a real tool, can support in business process and procedure optimization. Learn here how this… Read More »Mine the gap – modern business process optimization
GTIN, the Global Trade Identification Number has attention in the health care industry and is on the rise. Does the GTIN offer a valuable alternative… Read More »GTIN a potential alternative to the pharmacode and the UDI?