The handbook ISO 13485:2016 – Medical devices – A practical guideseeks to address all these expectations. Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, gaining the trust of customers and meeting regulatory requirements. However, implementing a quality management system that maintains the effectiveness of its processes and meeting applicable regulatory requirements can be challenging for the sector. These medical devices play an important role in the welfare of the public, whose safety depends on the quality and consistency of those medical products. Medical devices range from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants and software for disease screening.
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