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Canadian medical device conformity
Medical Standards and schemes
The In-Vitro Diagnostic (IVD) Device Regulation is approaching the final stages of the review process before becoming law and is the proposed revision to the existing IVD Directive 98/79/EC.
LRQA provides accredited certification and training services to ISO 13485, the quality management system requirement for manufacturers of medical devices.
We’re designated as a notified body under the medical devices directive for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.
Recognizing that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonized approach to auditing and monitoring the manufacturing of medical devices.
As with the upcoming In-Vitro Diagnostic (IVD) Device Regulation, the proposed Medical Device Regulation (MDR) is also approaching the final stages of development before becoming law as a Regulation.
The European Council released the final texts of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) last month.
Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organizations involved in medical device manufacturing.
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 recognized 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?
Join us as Susan discusses how to implement and maintain ISO 13485:2016 in order to help manufacturers ensure a successful transition to the revised standard.
This annual event hosts the global regulatory community and brings together regulatory professionals to share knowledge while addressing all things relevant to the dynamic medical device, pharmaceutical and biotech industries.
Following an update previously released by UKAS, medical device manufacturers need to transition to the revised version of ISO 13485 by 31 March 2019. Considering that this deadline is fast approaching, medical device manufacturers have to plan and implement their transition. Lloyd’s Register (LR) is delivering a webinar on implementing and maintaining ISO 13485:2016 to help manufacturers ensure a successful implementation.