ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Also covered will be:
- Medical devices: conformity assessment and the CE mark.
- How to conform to the legal requirements for placing medical devices on the market.
- Supporting Manufacturers in Working with Competent Authorities.
- MHRA Medicines & Healthcare products Regulatory Agency explained.
- Regulatory compliance and effectiveness with global regulatory agencies.
In addition there will be an opportunity to network and take part in a Q&A session with speakers.
Ed Ball – Maetrics’ Solutions Delivery Manager – will be on the panel of speakers, bringing his expert knowledge. Register here today.
6th December, 6-8pm at The Accelerator Building, Liverpool (UK)
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