Susan Stugelmeyer has over ten years experience supporting medical device clients with account management helping them meet their global translation initiatives. Her key areas of focus within the translation industry include driving client corporate goals throughout their global enterprise, recognizing areas of improvement and presenting solutions, and quality process.
On May 5, 2017, the European Commission released the new Europe (EU) Medical Device Regulations (MDR) in an effort to create a more unified and transparent system for medical devices. The MDR will become enforceable in 2020, and introduces new rules relating ...
The final versions of the European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were published in May of 2017, representing major changes to the EU’s medical device legislation. Although it’s been approved by ...
In the medical device industry, regulation is a big deal. Proper training for internal operations staff, and consumer and professional end users, needs to be done effectively in order to ensure patient safety and compliance. E-learning has emerged as a ...
Electronic Labeling (e-labeling) has the potential to be hugely beneficial to medical device companies creating Instructions For Use (IFU), labels and packaging information. But at the same time, the European Union’s 2012 e-labeling directive can be difficult ...
