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Improving Performance, Reducing Risk
Medical Device Single Audit Program Certification
Medical quality management
In vitro diagnostic device quality
Medical device directive
Canadian medical device conformity
Medical Standards and schemes
the Canadian Medical Device Regulations came into force, affecting all organizations represented as the “legal manufacturer” of medical devices (including in-vitro diagnostic devices) currently selling or seeking to sell into Canada through the device licensing system.
LRQA offers a solution to your time sensitive matters – eXpedite Fast-Track. As a responsible business working within the medical industry, you recognize the importance of providing quality products and services. Your clients and the industry expect this, and providing anything less could be catastrophic and even deadly. This is why you continue to take important steps and perform due diligence to help ensure consumers are protected and that legislative requirements are met.
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.
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