Writing for a Global Audience – Chicago
We will be hosting a complimentary Learning Unplugged seminar in the North Chicago area entitled, “Writing for a Global Audience.” This two-hour complimentary seminar is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker will explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.
The event will be held from 8:30 until 11am on April 24th at the Deerfield Hyatt. You can sign up here:
Best Practices for Software Localization – Santa Clara
On May 3rd in Santa Clara, California, we’re hosting, “Best Practices for Medical Device Software Localization,” to help device companies develop global-ready software that will work and be effective in any language and culture. According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Given this new attention on software by global regulators, proper medical software localization is now even more important.
The event will be held from 8:30 until 11am on May 3rd at the Biltmore Hotel in Santa Clara. You can sign up here:
Audio conference: Investigator Brochures for Medical Devices – April 18th
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time. Get more information and sign up here:
Audio conference: Agile Software Development in the Medical Device Industry – April 19th
Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D.
This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities. Get more information and sign up here: