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- Tag: medical-device
Tag: "medical-device"
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A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the ...
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...ust if you are planning to enter the US governative market. The NIST Special Publication (SP) 800 series applies to US federal agencies, organizations and their suppliers/subcontractors when c...
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There are some electronic records that a medical device manufacturer can easily manage in Confluence while others require a compliant document management solution. This post describes which records f...
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All product development teams let out a sigh of relief when a product is launched. The hard technical work is done, tight deadlines met (more or less), submissions completed and approved. Time to han...
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This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...
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In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...
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Your medical device software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Un...
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Risk management in the Regulated Industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It's a common misconception that risk management slows down...
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