BEST IN CLASS FOR INTERNATIONAL REGULATORY COMPLIANCE
Consulting, Auditing and Training Throughout the Product Lifecycle
Offering You Practical Solutions With Outstanding Results
Are you prepared for the new regulations? Regulation (EU) 2017/745 for medical devices and (EU) 2017/746 for IVDs sees major changes to current legislation including device classification and requirements for technical documentation. NSF’s expert consulting, auditing and training services can help you to prepare and stay in compliance. Get in touch to discuss your needs.
Our Services for Medical Devices and IVDs
EU MDR AND IVDR TRAINING
Our courses provide comprehensive instructions on the EU MDR and IVDR, covering key aspects of the regulation including new roles, conformity assessments and standard requirements for all manufacturers.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
YOUR EU IVD REGULATION READINESS HEALTH CHECK
Are you prepared for the May 2022 deadline? Many manufacturers are still underprepared for the new EU IVD Regulation (2017/746). Take our "health check" to assess your EU regulation readiness, the first step for putting things in order.
Looking for more resources? Our knowledge library holds a range of resources for medical devices and IVDs, including webinars, white papers and more.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
NSF’S TECHFILE FACTORY
Bring your technical documentation up to date with MDR and IVDR requirements. NSF’s TechFile Factory can perform an in-depth analysis of your MDD or IVD technical documentation to identify existing gaps, and provide recommendations on how to close them.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
NSF’s IVD APP – DOWNLOAD NOW FOR FREE
Stay up to date with the EU IVD regulatory updates and latest medical device industry news with NSF’s free in vitro diagnostics (IVD) app. Find all the IVD regulations in one place including Regulation (EU) 2017/746, EUDAMED guidance, information for notified bodies and more.
Download now by typing NSF IVD into the search bar of your app store:
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
Remediation Case Study
GMP remediation projects are rarely just about upgrading SOPs and retraining staff. John Johnson shares how the best firms use remediation projects proactively to alter the mind-set for quality and reduce ongoing costs to the business.
Get In Touch
For more information about the services we offer to the medical device industry visit our website or contact us at eudevices@nsf.org
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EU MDR AND IVDR TRAINING
Our courses provide comprehensive instructions on the EU MDR and IVDR, covering key aspects of the regulation including new roles, conformity assessments and standard requirements for all manufacturers.
YOUR EU IVD REGULATION READINESS HEALTH CHECK
Are you prepared for the May 2022 deadline? Many manufacturers are still underprepared for the new EU IVD Regulation (2017/746). Take our "health check" to assess your EU regulation readiness, the first step for putting things in order.
Looking for more resources? Our knowledge library holds a range of resources for medical devices and IVDs, including webinars, white papers and more.
NSF’S TECHFILE FACTORY
Bring your technical documentation up to date with MDR and IVDR requirements. NSF’s TechFile Factory can perform an in-depth analysis of your MDD or IVD technical documentation to identify existing gaps, and provide recommendations on how to close them.
NSF’s IVD APP – DOWNLOAD NOW FOR FREE
Stay up to date with the EU IVD regulatory updates and latest medical device industry news with NSF’s free in vitro diagnostics (IVD) app. Find all the IVD regulations in one place including Regulation (EU) 2017/746, EUDAMED guidance, information for notified bodies and more.
Download now by typing NSF IVD into the search bar of your app store: