Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid [...]
Regulatory FDA issues final rule removing certain software from medical device regulations The US FDA has issued a final rulemaking that eliminates certain software intended to [...]
Regulatory UK passes post-Brexit medical device regulatory bill into law The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, [...]
Regulatory Safer technologies program finalized by FDA A newly finalized guidance from the FDA smooths the path for manufacturers of devices and device-led combination products that stand to [...]
With the growth of medical device usage, the challenge for medical device developers and manufacturers for making the device safe for human use has significantly increased.
A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game-changing commercial solutions.
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