LRQA’s Gap Analysis assessment examines and reports on your management systems’ readiness for transition. It focuses on how your management system has addressed, or plans to address, the changes introduced through the publication in ISO 13485:2016.
The classification rules shown in this download will help manufacturers determine which classification applies to their medical device.
LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.
These classification rules will help manufacturers determine which classification applies to their in vitro diagnostic device (IVD). Download now!
Then, based on the classification of the IVD, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.
With the new IVDR expected to be published in Q2 2017, regulatory affairs professionals and device manufacturers are now seeking clarification on how to implement the new requirements within their organizations.
Do you have questions around the new MDR expected to be published in Q2 2017? Regulatory affairs professionals and device manufacturers are looking for answers and solutions on how to implement the new requirements.
This interview is the first of a two-part series where Susan Mecca, LRQA Technical Manager, Medical Devices, shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.
Overview of ISO 13485:2016 (Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes)
The new IVD Regulation (IVDR) will require sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation.