ciarahiggins, Author at Antaris Consulting

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

ISO Standards, Management Review / By ciarahiggins

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

Training / By ciarahiggins

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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Building a successful 5S team

ISO 9001, Quality / By ciarahiggins

The most important stage in implementing a 5S in an organisation is choosing a team of people to lead the effort. Having a 5S team ensures a certain level of focus around the 5S implementation process and gives momentum for a group effort to complete the project. The 5S implementation team should consist of a …

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Effective use of 5S floor marking for social distancing

COVID-19, ISO 9001, Quality / By ciarahiggins

In the current climate the more visual stimulation to re-iterate the message of good social distancing practices the better to limit the spread of COVID-19. Markings need to be clear and concise. If the visuals do not make sense, rules will be broken as people will not understand what is being asked of them. The …

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ciarahiggins

Transition from Medical Device Directive to Medical Device Regulation

Determining the Frequency of Management Review Meetings

Four best practices for creating and delivering engaging training content

Building a successful 5S team

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