“THE ONLY CONSTANT IN LIFE IS CHANGE.”- HERACLITUS Managing information goes straight to the heart of managing change. Why? Because without a rationale, checks and balances, evidence, and assurance of safety, information change – if left unchecked – can potentially lead to hazardous situations. This is especially critical in the intensely regulated medical device industry. […]
Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following […]
Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like […]
The delicate balance between investing and cost-saving at a venture-backed startup or SME is challenging. Particularly at pre-revenue, the CEO and leadership team must steward the capital responsibly and make tough decisions about where to invest – decisions that affect the company’s survival and success. In most medical device development projects, there are large amounts […]
Best-in-class, guided risk analysis and structured data management enable medical device companies to develop safe, regulatory-compliant products Lexington, Massachusetts, USA – March 4, 2020 – Cognition Corporation, a leader in SaaS solutions for guided compliance in medical device and pharmaceutical product development, has released a new suite of industry-leading risk management functionality in its Compass® […]
SITUATION Disconnected data and manual processes introduce a high potential for error in product development and can slow time to market. Companies can improve outcomes with the ability to cost-effectively develop medical devices in compliance with regulatory requirements, structure, and quality processes. SOLUTION Compass is a Software-as-a-Service solution that guides and automates the design control […]
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