How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.
Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.
Manufacturing jobs can be dangerous, but knowledge is the first step to minimizing the risks associated with these positions. This article discusses five of the most common safety hazards in medical device manufacturing, with tips on how to reduce the risk of employee injuries while maintaining productivity.
Vladimir A. Makatsaria, who most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business, has been appointed CEO of global medical technology company LivaNova. Former CEO Bill Kozy will serve a Board Chair.
Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.
“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward.”
“Flex’s proven track record of delivering complex electromechanical systems across diverse industries and deep understanding of the complex requirements for medical devices will enable us to accelerate time-to-market for our LUNA platform.”
The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data relevance and reliability, and considerations for methodologies for collection and analysis of real world data (RWD) to generate RWE.
Class 1 recalls are at a 15-year high. To reduce the number of recalls and nonconformances, medtech manufacturers need quality management and traceability processes that go beyond documenting and tracking changes to effectively connect people, processes and data.