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Case study related to most the frequent additional information requests from the FDA, analyzing over 10 recent submissions.

5 tips to help ensure that your medical devices not only meet FDA approval standards but also remain secure against evolving cyber threats. By prioritizing cybersecurity throughout the device lifecycle, you can enhance patient safety, data privacy and regulatory compliance.

The current supply chain difficulties are impacting revenue for many organizations, including General Electric Co. As product roadmaps are being re-evaluated and options for maintaining revenue expectations are evaluated, be sure your organization is not missing out on revenue from the largest part of product development – software! The ophthalmic industry discovered over a decade ago the importance and need for regular software revisions in order to provide the highest level of patient care as well as to stay competitive. If you currently have a consumables revenue stream, why not create a revenue stream out of software? These software product development initiatives come at both a development and regulatory cost.