Regulatory Webinar: Introduction to ISO13485

Date: 23/06/2020 | Time: 12:00 - 13:30
Location: Online event
Organised by: West of England AHSN and Medilink South West

Event summary

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

The requirements are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organisation. This presents a major barrier to innovators who are developing medical devices; as they need to consider whether to implement an in house ISO 13485 quality management system, and whether to outsource the development or manufacturing to a third party with ISO 13485 approved contractor.

Requirements and Implementation

This webinar provides an introduction to the standard and explores these two approaches together with a look at how it relates to CE marking.

Steve Cooper and Kevin Powell from Triteq, will provide an overview of the requirements of the standard and explores the routes to take a medical device through to CE marking. Keith Heaton from Nexa Medical, will then share their experiences of implementing ISO 13485 from the perspective of an SME.

Location

This Webinar will be held via Zoom. Joining Instructions will be sent upon registration.

Cost

Free

Programme

12:00 – Introduction (Richard Luxton)

12:05 – An introduction of the requirements of the standard and the routes to take a medical device through CE marking (Triteq)

12:35 – Q&A with Triteq

12:45 – An SMEs experience of implementing ISO 13485 (Nexa Medical)

13:05 – Q&A with Nexa Medical

13:15 – Wrap up and final comments (Richard Luxton)

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