Device manufacturers should actually be listening when a customer calls with a complaint. Although being on the receiving end of a complaint is never pleasant, your customers are trying to tell you something.
Don’t be that organization that fails to file MDRs. FDA takes the need to report adverse events very seriously, so failing to file MDRs is a mortal sin in the eyes of FDA.
Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
If clinicians performing clinical trials are categorized as Totally Restricted Investigators by FDA, then the clinical work is a wasted effort. Ensure that an appropriate level of due diligence is pursued prior to partnering with the clinicians selected to execute the clinical investigation.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
For those of you that are struggling to comply with 21 CFR, Part 820.50, you have two options: one, bite the bullet and script a reasonable procedure needed for effective purchasing controls, including supplier management; or two, embark on a ” hegira ” to escape the wrath of FDA.
Everything from unannounced notified body audits to a rescript of the directive into a regulation injected with steroids, changes are lurking on the horizon when it comes to the MDD.
The use of electronic filing will make your lives easier. Considering the initial requirement to report deaths and serious injuries was born in 1984, it is about time industry moved into the 21st century in regards to the reporting of adverse events.
Outsourcing manufacturing operations has been accepted as routine part of the product life-cycle process as device manufacturers are constantly weighing their options: build in-house versus outsourcing. What are some fundamental questions that need to be asked?
Whether you are thinking about Annual Planning or Year End Closing, we are in a time of reflection and resolve to improve. Over the years I have learned to choose a limited number of improvement efforts, apply management resources, then measure with them regularly for progress and impact. The costs of not focusing sufficiently in a few key areas can ruin a great idea.
