Heather Johnson - Profile and Journalist Details
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Get connected with journalists todayHeather Johnson
Verified
Marketing Content Writer, Freelance
Oakl
Beats
health & politics
non-fiction
Content
Medical Device Manufacturers Can Get Free EU Clinical Development Advice to Strengthen Strategy & Compliance
By Heather Johnson| Medical Device and Diagnostic Industry (MDDI) Verified The European Medicines Agency (EMA) and European Commission (EC) have introduced guidance, aimed at clinical study strategies, that are available to manufacturers before clinical investigations begin. Unlike the FDA’s Q-Submission program, this advice specifically applies to studies that have not yet started. At a GlanceThe EMA & EC offer free scientific advice for Class III & certain Class IIb devices before clinical investigations begin.
By Heather Johnson| Medical Device and Diagnostic Industry (MDDI) Verified The FDA Center for Devices and Radiological Health (CDRH) maintained a brisk pace after a record-breaking 2023. Among other activities — most notably, granting marketing authorization to novel devices — the agency kept the industry informed by way of dozens of guidance documents on everything from artificial intelligence to dental devices. All that activity comes in a year of transitioning leadership within the department and the agency at large.
Medical Device Manufacturers Can Get Free EU Clinical Development Advice to Strengthen Strategy & Compliance
By Heather Johnson| Medical Device and Diagnostic Industry (MDDI) Verified The European Medicines Agency (EMA) and European Commission (EC) have introduced guidance, aimed at clinical study strategies, that are available to manufacturers before clinical investigations begin. Unlike the FDA’s Q-Submission program, this advice specifically applies to studies that have not yet started. At a GlanceThe EMA & EC offer free scientific advice for Class III & certain Class IIb devices before clinical investigations begin.
Company Info
Freelance
Freelancer.com is the largest freelancing and crowdsourcing marketplace in the world, connecting over 81 million employers and freelancers across more than 247 countries. Founded in 2009 and based in Sydney, Australia, the platform allows employers to post jobs while freelancers can bid on these projects. It is publicly traded on the Australian Securities Exchange under the ticker ASX:FLN. The platform supports a variety of work categories, including software development, writing, design, and marketing. Freelancer.com also offers contests for creative work, where employers can award prize money to winning entries. Users can choose from different membership plans, including free and paid subscriptions, which provide various benefits. The mobile app enhances project management and communication for users on the go. With a diverse customer base that includes individuals, small businesses, and large enterprises, Freelancer.com plays a significant role in the global online economy.
De Pere, Wisconsin, United States