Viewpoints On Life Sciences Quality & Compliance

Guidance to accelerate compliance, reduce quality costs and protect brand reputation, while increasing safety and efficacy of products.

Most Recent Viewpoints

Marc Fowler Oval

Pic Veda Deshpande

Article Connecting the Digital Thread Across the Quality Lifecycle

by Marc Fowler, Benley Saint-Jean and Veda Deshpande

Johnhubert1

Cameron Carr

Article 5 Common Pitfalls When Approaching EUDAMED UDI Compliance

by John Hubert and Cameron Carr

Sachin Misra

Nick Ward 2016

Article AI in Pharma: Emerging Use Cases Across the Value Chain

by Sachin Misra and Nick Ward

David Wolf 2017

1ee63a6b1fe6 Max Huff 2020

Article Drive a Culture of Quality with Digital Quality Management

by David Wolf and Max Huff

David Wolf 2017

Dave Hadfield2023

Blake Snell 2018 2

Article Seven Leading Practices for Risk Management in Medical Device

by David Wolf, Dave Hadfield and Blake Snell

Nate Reisch 2014

Article 14 Reasons to Unify Regulatory Information Management with PLM

by Nate Reisch

David Wolf 2017

Johnhubert1

Article Leading Practices for EUDAMED and Basic UDI

by David Wolf, Erin Shaffer and John Hubert

Article PLM-Enabled Quality Compliance for Medical Device Part 7 – Production & Process Controls

by Teresa Jacob

Bryan Kissel 2018

Chad Markle 2018

Article Securing the IoMT – Nine Strategies You Can’t Afford to Overlook

by Bryan Kissel and Chad Markle

Pravin Kumar 2014

Rodney Holmes 2019 square

Article Key Considerations for the IoMT: Field Service Medical Event Debrief

by Pravin Kumar and Rodney Holmes

MACIEJ REDEL 1200x1800 Maciej Redel

Rodney Holmes 2019 square

Article Axeda End-of-Life: Now is the Time to Act

by Maciej Redel and Rodney Holmes

Article PLM-Enabled Quality Compliance for Medical Device Part 1 – PLM at the Core

by Teresa Jacob

Article PLM-Enabled Quality Compliance for Medical Device Part 2 – Design Controls

by Teresa Jacob

Article PLM-Enabled Quality Compliance for Medical Device Part 3 – Records, Documents and Change Controls

by Teresa Jacob

Article PLM-Enabled Quality Compliance for Medical Device Part 4 – CAPA

by Teresa Jacob

Article PLM-Enabled Quality Compliance for Medical Device Part 5 – Material Controls

by Teresa Jacob

Article PLM-Enabled Quality Compliance for Medical Device Part 6 – Equipment & Facility Controls

by Teresa Jacob

Bryan Kissel 2018

David Wolf 2017

Article Implementing IoT to Comply with GDPR: Five key transition benefits to increase ease of compliance with regulation EU 2016/679

by Bryan Kissel and David Wolf

David Wolf 2017

Article How PLI Can Decrease the Cost of Quality and Compliance

by David Wolf

David Wolf 2017

Article Streamlining your EU MDR Compliance Journey

by David Wolf

Thought Leaders

Dave Hadfield2023

Dave Hadfield

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