Suttons Creek

Who does what in a combination product's hazard analysis, risk assessments, and risk control? Click here to find the answers: https://lnkd.in/gkNkkKwR #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

A drug delivery system's risk priority levels will be based on designated definitions of severities of harm and scales of probability of harm. To review the crucial tools our consultants use for assessing risk and assigning risk scores, click here: https://lnkd.in/gn6_45rw #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

Mark your calendar for a trip to the future...of combination products with James Wabby of AbbVie and Suttons Creek's Courtney Evans. Use the below link to register for their ISPE webinar on April 30th at 10am EST, during which they will discuss the latest regulatory expectations and potential future innovation platforms and global convergence/harmonization initiatives for combination products. https://lnkd.in/gBZqmN9t #combinationproduct #drugdelivery #drugdeliverydevice #medtech #pharma #biotech #regulatoryaffairs #devicedevelopment

Imagine this common scenario...You are a large Pharma company with multiple drug delivery device systems in development. Two autoinjector programs with similar drug risk profiles and identical autoinjector devices are progressing a few months apart…and management realizes each team is using a completely different control strategy. The client asks us, “Is this something we should be concerned about?” Find out our general answer when we are asked this question by signing up for our email list: https://lnkd.in/gA4ngeWi #combinationproduct #drugdelivery #deliverydevice #devicedevelopment #pharma #biotech #medtech #controlstrategy #fda

A common postmarket work gap that occurs for combination products is defining when periodic risk reviews should occur. These reviews need to be defined per procedure and documented. Items typically evaluated as part of a periodic risk review include safety data (complaints), internal data (manufacturing data, audits), published literature or changes to state-of-the-art, and the organization’s RMF (are changes necessary to risk assessments, risk controls, labeling, etc.?). For more information on postmarket risk management, click here: https://lnkd.in/gD3AW-ya #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice?

Last month we published Part 1 of?Kelly Wedig's article?"Risk Management for Drug Delivery Systems", giving a birds eye view?of what a combination product risk management process looks like. We have recently followed up with Part 2, which provides tips for executing that risk management process.?Read it here: https://lnkd.in/e7MiUat5

What deliverables should your combination product risk management process generate? And who is responsible? https://lnkd.in/g2RguZJm #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

What should risk management look like for a combination product? https://lnkd.in/gDGT5q_5 #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

The FDA released a number of guidance documents in early January 2025 as the change of federal administration approached, and we have insights on the first important documents of note?related to use of Artificial Intelligence. We will be sharing them with our email subscribers this Thursday at noon (Pacific). To receive the information, simply sign up here: https://lnkd.in/gA4ngeWi #combinationproduct #artificialintelligence #ai #biotech #pharma #medtech #devicedevelopment #fda #regulatoryaffairs #deliverydevice #drugdelivery

An everyday life example of applying risk management to help you better understand how to apply it to combination products: https://lnkd.in/grW7NpvH #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement