What Should (and Shouldn’t) Go In a Technical File for MDR?
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked…
COVID-19 EUA and Enforcement Policy Transition Plans
In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
The FDA has announced that their current quality system regulation will be replaced by one incorporating references to ISO 13485:2016. This is a major change in…
MDR Transition: Why the Change, and What are the Changes?
Changes to European regulations have sparked a lot of talk about new requirements. Around the globe, many wondered what these changes meant, and how they would…
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of…
5 BOLD Predictions for Medical Device Quality in 2022
In our upcoming webinar for emerging medical device companies, we will elaborate on these five bold prophecies, enabling you to peer into our crystal ball and…
At Long Last: FDA Updates Software Guidance (Part II of II)
As noted in Part I, last week the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This…
At Long Last: FDA Updates Software Guidance (Part I of II)
On November 4, 2021, the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This guidance, the first…
New FDA Guidance Regarding Bench Testing
The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports…
FDA Digital Health Center of Excellence Listening Sessions
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…