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Transition from Medical Device Directive to Medical Device Regulation

Introduction ‘The Medical Device and In Vitro Medical Device Regulations represent the most significant change to European legislation for medical devices in over 20 years’ (Hoxey). As of the fifth of May 2017, new MDR and IVDR regulations have been approved and published by the European Commission. The new regulations will replace the directives; MDD, …

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Determining the Frequency of Management Review Meetings

The objective of management reviews is for top management to examine the effectiveness, appropriateness, applicability, and adequacy of the quality management system as well as safeguarding the products safety, effectiveness, and quality. ISO 13485:2016 ISO 13485:2016 requires management review meetings to be held at ‘planned intervals’, with no requirement for them to be held at …

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Four best practices for creating and delivering engaging training content

First and foremost, it is important to determine why your organisation needs training. Is carrying out the training simply a tick the box exercise or will it improve the performance of the business i.e., will it reduce costs, improve efficiency, mitigate risks, and/or generate revenue. This should be determined during a training needs analysis meeting …

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