Upcoming Live Webinars
Title Date Start Time Duration Register From Residues to Risk: The Role of Cleaning Validation in Biocompatibility Assessments
Cleaning validation and biocompatibility are distinct regulatory requirements—cleaning validation is designed to demonstrate that a device or component can be consistently and effectively cleaned to remove manufacturing residues or contaminants, while biocompatibility evaluates the safety of the finished device when in contact with the body. However, in select circumstances, data from a robust cleaning validation study may provide supportive evidence in the context of biocompatibility, particularly when assessing the impact of a manufacturing or supplier change.
For example, if cleaning validation confirms that process residues are removed to well below toxicological concern, this information can help mitigate uncertainty about whether the change introduces new biocompatibility risks. While not a substitute for chemical characterization or toxicological risk assessment, cleaning validation can, in these cases, complement biocompatibility evaluations as part of a holistic justification.10/15/2025 2:00pm EDT 1 hour Register Getting Material Selection Right the First Time
Modern medical device design demands strategic material selection from the outset due to market pressures and regulations. Dr. Gavin Braithwaite, Cambridge Polymer Group's CEO, explores key forces impacting medical device design and material choice.
-Iterative development of conventional devices
-Influence of market trends and regulations
-Historical example of orthopedic implants
-Risks of relying solely on traditional specifications
-Importance of early material science expertise
This webinar will identify emerging forces that can disrupt development, including:
-EU MDR and regulatory changes
-Manufacturing trends (e.g., ethylene oxide sterilization alternatives)
-Miniaturization impacts on material properties
-Combination device challenges
-Unique requirements of degradable materials and hydrogels
Attendees will gain valuable insights into how to think about material selection and what considerations must be accounted for outside of the standard specification sheet.
Learn how to select the right material – the first time around.
11/12/2025 2:00pm EST 1 hour Register
Past Webinar Recordings
Recording name Created Date Download Material Deformulation: Because Ignorance Is NOT Bliss (Especially When Your Product Fails) 9/17/2025 Download Squeezing the Most Out of Medical Device Hydrogels 8/13/2025 Download The Tightrope of Tentative IDs: Balancing Analytical Uncertainty with Toxicological Risk Assessment 7/9/2025 Download Considering Medical Device Manufacturing Changes? Proactive Strategies for Effective Risk Management 6/11/2025 Download