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If you have received your ISO 13485 Assessment Report and it contains non-conformances, you must provide your Notified Body / Third Party Registrar with a corrective action plan for addressing the non-conformities. Regulatory Insight can assist your company to devise corrective action plans that me…
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We have treated a large number of patients with Spinal Cord Injuries with both the AutoMove 800 and the new NeuroMove NM900. The results vary, but are very similar to the results seen for stroke survivors, i.e. approximately 90% have achieved and maintained significant functional improvements.
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It's true. Data is power and medical device manufacturers need a lot of it. Numerous data sources exist to provide data-driven solutions to these — and many other challenges faced by medical device firms every day. Identifying the best data sources, mining the databases for relevant data, and deter…