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LRQA provide a range of services for the medical device industry including certification and training in ISO 13485.
Medical Quality Management
In Vitro Diagnostic Device Quality
Medical Device Quality
LRQA has launched a transition support club for Medical Device Manufacturers. By becoming a member you will receive relevant information and support on the new regulations.
View the latest edition of the LRQA medical training guide. ISO 13485, the international Quality Management System’s standard for medical devices, has been revised and officially published by the International Organization for Standardization (ISO) - our range of training courses with help you on your transition journey.
Own Brand Labelling of Medical Devices: Clarifying Current Expectations for CE Certification.
Find out how ISO 13485 certification paves way for Oceanz to apply life-saving medical 3D printing technology on a global scale.
LRQA’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, LRQA will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) so that LRQA remains as an EU recognised Notified Body for Medical Devices post the UK leaving the EU.
The Netherlands presidency of the Council and representatives of the European Parliament (EP) reached a political agreement on the new Medical Devices Regulations and In Vitro Diagnostic Devices Regulations (IVDR) yesterday. When will the new regulations be published, and what does this mean for medical device manufacturers and Notified Bodies?
Theresa Jeary, LRQA Technical Manager Medical Devices, recently contributed an article on Own Brand Labelling to the May edition of Regulatory Rapporteur, a leading international journal for professionals in regulatory affairs within the healthcare arena.
The medical regulatory landscape is undergoing its most significant overhaul in years, and with that comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation. As we progress towards the publication of ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes), we interviewed John Howlett, LRQA Medical Devices Technical Manager, for his views on the current status of the revision to ISO 13485.