ISO 13485 Medical Devices

ISO 13485: Medical Devices Quality Management Systems – Requirements for Regulatory Purposes – is a quality standard based on ISO 9001, which is exclusively

applied to medical device manufacturers. An entity must be manufacturing medical devices or subcontracting this activity in order to become certified to ISO 13485. ISO 13485 is based on the ISO 9001 standard but with additional requirements in relation to:

• Design
• Environmental Control
• Traceability
• Documentation
• Records Control
• Regulatory Actions
• Risk management

Mackin Consultancy can fully manage the introduction, implementation and certification of ISO 13485 in your company. This service entails the presence of one of our ISO 13485 consultants on-site for one to three days per week, depending on the timescales involved, for the duration of the project. A typical timeframe is six to twelve months, depending on the resources available and the level of documentation already in place.

During this time the consultant may act as an interim quality manager, thus providing continuity throughout the project. The following activities are included in this service:

• Project planning (a detailed map of the activities to the completion of the project)
• Document preparation (including industry specific templates, customised to your business)
• Delivery and co-ordination of the required training throughout the project
• Document and change control administration
• Liaising with external bodies on quality and regulatory matters
• Co-coordinating the external audits and ensuring that the company is adequately prepared prior to the audits
• Support the preparation of formal responses to the external audits

Consultant Profile: Angela O’Sullivan

Angela has successfully managed the implementation and certification of ISO 13485 in several Irish medical device start-up companies. With many years’ experience in quality management systems, in 2009 Angela started to focus almost exclusively on the medical device sector. Her aim is to develop a tailored solution for each client so that they are adequately supported to meet their commercial timelines.

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