When drug meets device: How to assess compatibility?
The frequent use of combined products, which involve the joint application of drugs and medical devices, underscores...
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Supply Chain Management Audit Effectiveness and Oversight
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...
The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device
Evaluating the biocompatibility of medical devices is a critical step in ensuring patient safety, and it should...
The Essence Of The EU MDR and its Key Consequences
The enhanced focus of the European Union Medical Device Regulation (EU-MDR) on biocompatibility and toxicity represents a...
ICH Stability Testing and Method Development
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...
Biocompatibility of Raw Materials for Medical Devices
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
The New ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices
In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of...
Changes to ISO10993-1 and relationship to Medical Device Regulation
The 2018 revision of ISO 10993-1 aligns closely with the Medical Device Regulation (MDR) to provide clearer...
Design Control for the Contract Research Organization
Design Control is a fundamental requirement set forth by the FDA, detailed in 21 CFR 820. It...
If Something Looks Clean, Is It Really Clean? Cleaning Validations for Reusable Devices
Reprocessing validations of reusable medical devices have often been overlooked. However, the upcoming Medical Device Regulation (MDR)...