Recently, biocompatibility consultant, MedTech enthusiast and chemist, Marina Daineko, shared a series of LinkedIn posts defining, medical device biocompatibility and the need for a Medical Device biological risk assessment “framework.” Following is a reposting of Marina’s original LinkedIn series.
Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.
The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in pre-market applications.
The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
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.
Surface science sheds light on certain properties to help interpret and precisely control these behaviors, allowing OEMs to innovate with confidence.
In order to meet the worldwide need for faster and affordable testing processes, companies must shift goals and apply resources to ending this pandemic.
Adhesives are ubiquitous. With virtually limitless applications, the retail stick-to skin market is a good choice for companies looking to expand their product offerings.
