Key Challenges for Risk Management in Medical Device Development
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Risk management is a full life-cycle activity for medical device development
ISO 9001:2015—Establishing the Context of the Organization
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Context. What the heck is that and how do you apply the term to your organization?
Credit: Takako Tominaga
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
When Foreign Firms Are No Longer Welcome
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.
Keeping Pace With Evolving Technologies
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Four Beneficial Byproducts of Automating Your Corrective Actions
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Can you imagine trying to do CAPA faced with this?
Credit: Dave Wilson Cumbria
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Avoiding and Managing Product Recalls
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Safe products are good for the consumer, good for the manufacturer.
Credit: Jim Makos
Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.