Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Tag Archives: regulatory
Artificial Intelligence Boosts New Era of Postmarket Intelligence
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
Biopharma and Medical Device Trends Investors Should Watch in 2022
For private equity and venture capital investors alike, there are five key trends presenting both headwinds and tailwinds that may impact investment flows into 2022.
Strategies You Cannot Overlook to Achieve Success in Japan’s Medical Device Market
Although opportunities in Japan are still considerable, foreign device companies need to do their homework to be successful.
Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies
Intensive chemistry requirements are creating massive data sets of chemicals, all of which need to be assessed for biological safety. This deluge of data is making equivocal results far more common than ever before. Fortunately, manufacturers can take steps to mitigate risk and support the safety of their products.
Countdown to June 2023 for UKCA compliance
This article highlights what manufacturers should prioritize and areas in which new information may still emerge, along with providing a starting point for businesses that need to familiarize themselves with the UK Conformity Assessed marking requirements.
Why Documents and Data Can No Longer Be Treated as Distinct Entities
If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.
The MDR and Opportunities for MedTech
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
AI in MedTech: Risks and Opportunities of Innovative Technologies in Medical Applications
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
