Quality of product or service is the critical success factor in the healthcare industry. Driven by an increasing number of healthcare issues over recent years, governments worldwide have increased their focus on regulating businesses designing, manufacturing, and distributing medical products and services. Ever more demanding regulatory requirements and standards have been issued and the enforcement powers of agencies responsible for patient safety have increased. This response is understandable but has thrown up several unique and critical dilemmas for businesses in the healthcare sector.
Whether increased regulation translates into improved patient safety is yet to be seen. It can certainly be argued that the effort and resources required ...
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