The GSPRs (General Safety and Performance Requirements) The Heart of the EU IVDR
This whitepaper compares the essential requirements (ERs) described in the EU IVD Directive with the general safety and performance requirements described in the new EU IVD regulation.
Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections
This white paper by expert Rob Ruff provides a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.
Your Free EU IVD Regulation Readiness Health Check
Take our "health check" to assess you EU regulation readiness, the first step for putting things in order.
Exploring the Relationship Between the IVDR and the IVDD
Use this tool to clarify the corresponding relationships between the general safety and performance requirements defined in the IVDR and the IVDD.
Navigate the regulations for in vitro devices
In vitro diagnostic devices (IVDs) are subject to stringent regulation across the EU. Robyn Meurant, executive director for the IVD and medical devices regulatory team at...
NSF PH White Paper - Steamlining Pharma Operations in the Wake of COVID-19
EU MDR: what does it mean for the medical device industry?
Founded in 1944, NSF International’s mission is to protect and improve global human health. Manufacturers, regulators and consumers look to NSF to facilitate the development of...
Live system updates - Why do them?
I have a vivid memory of a certain “pre-exam stress” period as my old production site prepared for my first regulatory inspection in the early 1990s. The theory, even then, was that...
The do’s and don’ts of responding to deficiencies during FDA Premarket Review
Navigating through the FDA submission review process can be challenging, time-consuming, and labour and resource-intensive. The following do’s and don’ts serve as a starting point to...
Understanding Japanese medical device approval process
Learn about the regulatory approval process required for medical devices to enter the Japanese market.
EU MDR: What does it mean for the medical device industry?
Kim Trautman looks at the key changes occurring with the EU MDR, including additional post-market surveillance. She explores how companies can prepare for the May 2020 deadline,...
The GSPRs: Heart of the IVDR
The heart of the EU regulation of in vitro diagnostic medical devices lies in allowing market access to IVDs that offer clinical benefit, and are safe to the patient.
The benefits of joining MDSAP
Medical Device Network spoke to NSF International’s executive director for medical devices, Brian Ludovico, about the advantages of joining the Medical Devices Single Audit...
Regulatory and clinical strategy services
NSF offers comprehensive expert FDA regulatory and clinical strategy support, providing a range of specific services to meet all your regulatory needs.
Drug-device combination products
The EU Medical Device Regulation comes into effect on 26 May 2020, replacing Directives 93/42/EEC and 90/385/EEC and amending 2001/83/EEC. This article from Pete Gough and...
Navigate the regulations for in vitro devices
In vitro diagnostic devices (IVDs) are subject to stringent regulation across the EU. Robyn Meurant, executive director for the IVD and medical devices regulatory team at...