US FDA Decoding the 510(k) Approval Pathway: Regulatory Success in Medical Device Clearance bySCIENCE ARENA -November 25, 2023 The 510(k) submission to the FDA is a pivotal step for marketing a medical device for human use …
Medical Device Compatibility of materials used for Sterile Barrier Systems with sterilization processes bySCIENCE ARENA -November 19, 2023 A sterile barrier system refers to the packaging components that are designed to maintain the st…