Abstract
In Healthcare the importance of compliance to existing regulatory and normative requirements has grown significantly over the past few years. Continuous adaptation of Legislation and Standards for both Medical Device Manufacturers (MDM’s) and Healthcare Delivery Organisations (HDO’s) were dedicated to improve protection of Operators and Patients. This Framework has two conformity approaches: Product testing and Quality Management System Auditing. Both have their limitations in terms of appropriateness and affordability for organisations of different sizes and structures. Processes are getting more attention when it comes to evaluating the quality of their output. Therefore Process Certification is becoming increasingly popular, considering its obvious added value, modular scope and favourable cost/benefit ratio.
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