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Many products must go through a risk management process to ensure safety, but it\u2019s the severity of the potential outcomes that vary.<\/p>\n
For our customers creating products in heavily-regulated industries \u2014\u00a0such as automotive<\/a>, medical devices<\/a>, and aerospace<\/a> \u2014 the consequences associated with not correctly mitigating risk puts lives in jeopardy. And there\u2019s ample evidence that too many in these fields are still struggling to find a process that works.<\/p>\n Even while tougher safety regulations and standards are being enacted, product recalls are still soaring. In February<\/a> and March<\/a> alone, millions of vehicles were recalled due to quality issues. And, within the fourth quarter of 2018, recalls of medical devices spiked 449% to just over 161 million<\/a>, which was the second highest quarter in at least 14 years.<\/p>\n These examples showcase why teams building complex products need a smarter way to identify the probabilities and severity of risks early so they can track and mitigate them throughout development. And while risk management<\/a> is imperative, it can\u2019t come at the expense of the speed of development; in fact, it should complement rather than hinder efficiency.<\/p>\n Earlier this year, we introduced Jama Connect\u2122 Risk Management Center for medical device developers<\/a>, and now we\u2019re excited to announce that we\u2019re opening it up to all our customers working within regulated industries with the introduction of FMEA templates.<\/p>\n The Jama Connect Risk Management Center<\/a> was developed from best practices learned from our work with companies that deliver quality products in safety-critical industries. With the newly-updated Risk Management Center, development teams can participate in risk management techniques including Preliminary Hazard Analysis (PHA) and FMEA in accordance with ISO 14971 and IEC 60812.<\/p>\n As an overview, here are some common problems we\u2019ve often seen around managing risk and how the Jama Connect Risk Management Center solves them.<\/p>\n Risk management is a daunting challenge, especially for startups vying to disrupt an entire industry. Whether it\u2019s ISO 14971, IEC 60812, or beyond, many new companies aren\u2019t sure where to start when creating a risk management plan to bring their products up to international standards and government regulations.<\/p>\n In Risk Management Center, users receive guided templates based on best practices like FMEA and ISO 14971, which helps remove the bulk of the guesswork.<\/p>\n For medical device developers, Jama also has a Professional Services division that can work directly with your team to provide the best possible start to your process in accordance with ISO 14971. Through training and consultation, they\u2019ll help customize your templates in a way that matches your team\u2019s risk management process so you can start managing and mitigating risks quickly while accelerating development.<\/p>\n Jama\u2019s professional services dramatically speed time to value, so much so that one customer began developing medical devices in less than a week<\/a> with our guidance.<\/p>\nProblem: Not sure how to implement a solid risk management process<\/strong><\/h2>\n
Solution: Pre-configured risk analysis templates and startup services<\/strong><\/h2>\n