Designing with security in mind is proving to be essential for OEMs in the embedded space. But exactly what that means remains a moving target: What’s secure today is not necessarily secure tomorrow. In volatile industry environments where threats are non-stop, OEMs want to secure their devices and systems, but don’t necessarily understand how to maintain protection for the long term. A smart approach features design strategies and standards, but as importantly, is grounded in a security-driven mindset that embraces security implementations and deals proactively with different risks. This kind of vigilance can prevail in many ways: protecting systems, distinguishing OEMs, and driving new opportunities to create long-term profit centers from security services.
Read More →Reduce Supplier Risk, Reduce Organizational Risk
Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.
Read More →Best Practices for Medical Device Development
Medical device developers must take into account numerous safety, quality and risk factors to ensure the durability and safety of their devices. Developers must also adhere to strict risk management processes and life cycle requirements that may vary regionally. Our friends at Seapine Software have generated the whitepaper below to help developers navigate this shifting terrain and understand the best practices for exposing risk throughout the product development life cycle. Exposing Risk Throughout Your Product Development Lifecycle Hear more from Seapine Software by joining the discussion at the American Medical Device Summit 2016!
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