Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
Driven Coding Solutions to Combat Rising Claim Complexity, Coder Shortages, and Reimbursement PressuresDelray Beach, FL, Feb. 04, 2026 (GLOBE NEWSWIRE) -- The Global Medical coding market is projected ...
Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...
As an authorized MDSAP Auditing Organization and a designated EU Notified Body, DNV is permitted to conduct audits under both certification schemes. This dual authorization allows manufacturers to ...
ValGenesis Inc., the global leader in digital validation lifecycle management, today announced that a leading vaccine manufacturer will use its platform to digitalize and standardize equipment ...
The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
ProMed, a contract manufacturer specializing in liquid silicone rubber (LSR) and highly regulated combination products, has announced new process refinements in the LSR injection molding process ...
Dec 9 (Reuters) - Medical device maker Teleflex (TFX.N), opens new tab said on Tuesday it would sell three units for a combined $2.03 billion, as it sharpens its focus on its critical care and ...
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