Newsletter | May 6, 2023

05.06.23 -- April's Most Popular Articles & Solutions
 
Featured Editorial
The Road To ISO 13485 Certification: Tips For Effective Audits
 
By Joanne Rupprecht, Boulder iQ

Follow these best practices to prepare for and conduct an audit for your medical device quality management system compliance with regard to ISO 13485.
Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
 
By Arif Noorani, Christopher Fanelli, David Ludlow, and Raj Pai, Sidley Austin LLP

We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
The FDA Regulatory Landscape For AI In Medical Devices
 
By Michele Buenafe, Jake Harper, and Andrew Gray

This article reviews the existing FDA programs impacting artificial intelligence (AI)/machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.
Top Industry Insights
Effective Communication Drives Successful Manufacturing Transfers And Productive CMO Relationships
White Paper | By Bob Khin, Flexan

While lift-and-shift scenarios — wherein manufacturing is moved from one site to another without product or manufacturing process redesign —are ideal, they also are a rarity.
Change Control: Considerations For Medical Device Components
Article | By Paul Priebe, Qosina Corporation

Explore the various factors that must be considered when faced with modifications, and what processes must be implemented in advance as part of a robust quality management system.
CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors
Article | By Brandon Zurawlow, Principal Consultant at Containsure

Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity testing strategy. Learn about these challenges and how to overcome them.
Top Resources
Creating Opportunity In The Life Sciences Industry With Modeling and Simulation
Dassault Systèmes Americas
High-Viscosity Formulations: A ‘Human Solution’ To Autoinjector Design
By Jonathan Bradshaw, Oval Medical Technologies
Uni-Patch S Series (Starburst) Stimulating Electrodes
Cardinal Health, Inc.