Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.
Google has reportedly pledged not to use Fitbit’s user data for its advertising business. With the deadline quickly approaching, is it enough that European regulators will approve the deal?
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
The Medical Device Regulation’s objective is to improve patient safety by evaluating existing devices and ensuring transparency throughout a device’s lifecycle once it has gone to market. Some experts predict that up to 50% of medical devices could be taken off the market as a result of it.
In what was reported as an "unprecedented backlash," trade groups representing U.K. drugmakers - as well as four other industries - for the first time expressed concerns about a possible Brexit deal, having previously been more concerned about a possible no-deal Brexit.
A report, by the UK Bioindustry Association, found that venture capital investment in UK biotech companies rose from $178 million in first quarter 2018 to $240 million in first quarter 2019.
Many supporters of the UK's withdrawal from the EU say "no deal, no problem," but drugmakers' actions suggest "no deal, big problem."
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
Ian Hudson, CEO of the MHRA, will step down in September 2019. He cited the country's withdrawal from the European Union as a key factor.
The IEC 60601 standard is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling, and risk management.
March 31, 2019, is the date by which all companies that are currently 13485 certified need to have transitioned to the 2016 regulations. Here's a checklist of what medical device companies need to do to comply.
From the EU MDR/IVDR being revised to the MDSAP program going live, regulatory changes have been rampant and significant for medical device professionals.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
The decision comes at a time of regulatory upheaval in the European Union.