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Total Product Lifecycle Solutions for the Medical and In Vitro Diagnostics Industry Thursday, May 26, 2016 NSF Health Sciences Medical Devices team are recognised as training-experts for regulatory and quality, as well as for consultancy and...

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FDA Issues Draft Guidances With New Regulatory Pathway Options for PMA Products Thursday, May 26, 2016 In April 2014, the FDA released draft guidance documents for premarket approval, Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (PMA) and...

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EU Medical Device Regulations: Are You Ready for the Impact? Thursday, May 26, 2016 Establishing in-vitro diagnostic products and medical devices in Europe may mean making changes to your business beyond comprehension of new regulatory...

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Preparing for Unannounced Inspections from Notified Bodies Thursday, May 26, 2016 Vice-president of Europe-health sciences medical devices at NSF International has offered advice on how to prepare for unannounced audits by notified bodies after Europe introduces further...

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Changing the Quality Culture Monday, March 28, 2016 People are generally happy sticking to what they know, to their tried and tested habits as it is easy and painless....

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COPQ in the Pharmaceutical Industry Tuesday, March 22, 2016 COPQ is increasingly valuable for the pharmaceutical and medical device industries, where maximising product quality is paramount and defect reduction has an additional knock-on...

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Deficiencies in QMS Thursday, March 17, 2016 The MHRA has been one of the few regulatory authorities to publish the statistics and classifications for the deficiencies it finds during inspections....