COMPLIANCE WOES?
TIME IS RUNNING OUT FOR COMPANIES TO PREPARE FOR MDR/IVDR...
The upcoming MDR and IVDR will present significant challenges for manufacturers and the way they manage compliance.
The Medical Device Regulation (EU MDR) 2017/745, which comes into effect on 26 May 2020, introduced major changes for manufacturers placing devices on the European market. These include changes to device classification, requirements for technical documentation and clinical evidence, and new obligations for economic operators. The IVDR brings even more changes.
NSF International provides the tools and solutions to ensure you comply with the new EU regulations. We do this through a range of consulting services, including regulatory and clinical strategy planning, quality audits, training courses and the development of regulatory submissions. By helping you to navigate the significant EU MDR and IVDR changes, we can support your transition and help you build in compliance at an early stage.
Regulatory Affairs
NSF’s industry experts can help you to navigate regulatory challenges including submission to FDA and Chinese authorities, and your transition to EU MDR/IVDR compliance.
Quality Management
Certification to relevant standards is critical. NSF can help identify the gaps and help you fill them.
Clinical and
Performance Evaluations
Are your clinical evaluations up to date and comprehensive? Our experts can help you update or improve your clinical evaluation report, including performance evaluation for IVDs.
Audits and
Inspections
NSF can help you to prepare for upcoming audits including the MDSAP auditing process, we also provide ongoing advice for the maintenance of your quality management systems.
Training and Education
NSF is a leading provider of training courses and education, which can be tailored and delivered in-house according to your needs.
If you are concerned about compliance, or would like more information about our IVD and Medical Device services – contact us.
NSF’s IVD App Coming Soon
The ideal place for you stay up to date with the latest IVD regulatory updates as well as other key medical device news – get notifications straight to your device. You can also access free resources including our latest webinars and white papers from NSF’s industry experts.
For more information about the services we offer to the medical device industry visit our website or contact us.
