Open Access. Powered by Scholars. Published by Universities.®
Physical Sciences and Mathematics Commons™
Open Access. Powered by Scholars. Published by Universities.®
- Discipline
- Publication
Articles 1 - 2 of 2
Full-Text Articles in Physical Sciences and Mathematics
Changes To The International Regulatory Environment, Martin Mchugh, Fergal Mccaffery, Valentine Casey
Changes To The International Regulatory Environment, Martin Mchugh, Fergal Mccaffery, Valentine Casey
Articles
Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The …
Developing A Promo Video In Premiere Elements: A Day In Dublin, Jerome Casey
Developing A Promo Video In Premiere Elements: A Day In Dublin, Jerome Casey
Instructional Guides
No abstract provided.