NSF International: White Papers

NSF PH White Paper - Steamlining Pharma Operations in the Wake of COVID-19
Wednesday, October 14, 2020

EU MDR: what does it mean for the medical device industry?
Monday, May 11, 2020 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?
Thursday, February 13, 2020 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
Friday, February 07, 2020 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
Friday, February 07, 2020 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?
Friday, February 07, 2020 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
Friday, February 07, 2020 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
Friday, February 07, 2020 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
Friday, February 07, 2020 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
Friday, February 07, 2020 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
Thursday, May 30, 2019 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...

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