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5th of Five blogs covering each of the listed steps in the medical device process

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Final delivery and validation of a medical device at a customer site is a significant achievement for all.

When control of the device is transferred to the customer, it represents the culmination of what may well be years of effort among thousands of people. Finally, patients have the opportunity to benefit from the tremendous investment of work and intellectual capital that must be involved.

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2nd of Five blogs covering each of the listed steps in the medical device process

ISO 13485 is a global standard for quality management and assurance in medical devices. In previous posts, we have discussed the basis of the standard and its comprehensive nature. Because of its rigorous detail, it empowers organizations to adapt to the many serious challenges of preparing their devices for commercialization and executing according to the highest regulatory expectations.

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1st of Five blogs covering each of the listed steps in the medical device process

post2ISO 13485 is the leading global standard in medical device quality management. The fact that it is comprehensive is a key reason it stands above all other attempts to synthesize expertise on this complex subject. It offers crucial guidance through each phase of product design, management, distribution, and installation calibrated to achieve success in a regulation-driven global market.

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