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Materials
Hidden PFAS in Supply Chains Create Compliance Uncertainty
How medical device manufacturers should respond to the new EPA ruling.Online Exclusives Dr. Bruce Jarnot, Regulatory & Sustainability Expert, Product Sustainability, Assent 11.08.23
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Femasys Regains Nasdaq Compliance
The company was previously notified of noncompliance with the minimum bid price rule on June 1.Sam Brusco, Associate Editor 10.11.23
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Software & IT
IEC 81001-5-1: A Cybersecurity Pathway for FDA and MDR Compliance
Regulatory bodies require manufacturers to implement cybersecurity measures during design and development stages.Christopher Gates, Director of Product Security, Velentium 07.20.23
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RQM+ Acquires Giotto Compliance
Giotto Compliance will operate as an independent RQM+ business unit.Michael Barbella, Managing Editor 04.06.23
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Why Medtech Quality Investments Should Not Only Focus on Compliance
Insights to position technology as a competitive advantage, accelerate implementations, and improve quality processes over the long term.Carl Ning, Senior Director, Quality Strategy, Veeva Systems 03.10.23
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Surgical
Titan Medical Lays Off Senior Leadership; Loses Nasdaq Compliance
Company no longer complies with Nasdaq’s audit committee requirements in Nasdaq Rule 5605.Sam Brusco, Associate Editor 02.14.23
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How to Achieve MDR Compliance
The new Medical Device Regulation applies to all manufacturers who intend to sell medical devices in the European Economic Area.Online Exclusives Martina Pieper, Senior Marketing Manager at Dunlee 12.08.22
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Software & IT
How eQMS Enables Connected Compliance in Life Sciences
Integrating quality processes and making regulatory compliance easier.Online Exclusives Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA 07.12.22
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Jeffrey Sachs Hired as Balt's Chief Legal and Compliance Officer
Sachs has more than 25 years of experience in relevant legal and compliance positions.Globe Newswire 02.24.22
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Software & IT
Cost-Effective Test Automation for Medical Device Software Quality and Compliance
Presentation from the European Medical Device Software Development and Compliance Virtual Conference.Videos Auriga Inc.
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Guided Therapeutics Passes Required Compliance Testing for Clinical Trials
Company anticipates Chinese approval next year for its LuViva Advanced Cervical Scan.Business Wire 10.14.21
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Digital Health
ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance
Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.Business Wire 07.09.21
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Video & Analytics: Differentiators in a Compliance-Adherent Crowd
Instead of checking the box with minimal investment in compliance, the firm that elevates its manufacturing practices beyond cGMP will gain more market share.Prasad Akella, Founder/CEO, Drishti 05.03.21
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Ensuring Regulatory Compliance for Medical Device Manufacturing
EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices.Tim McGinnis, Vice President, Medical Quality and Regulatory Affairs, Sanmina 05.03.21
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Packaging & Sterilization
Ensuring Labeling Compliance Within European Markets
Upcoming EU Medical Device Regulations will mean a shift to digital processes.Online Exclusives Bob Tilling, VP Global Sales, Kallik 11.13.20
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SaaS Solution Introduced for Guided Compliance in Medtech Product Development
Cognition Corporation's solution is designed to automate the product development process in compliance with industry standards.PR Newswire 08.24.20
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Keeping Compliance on Track Through Testing
The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation by one year.Sandi Schaible, WuXi Medical Device Testing 05.01.20
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Cardiovascular
FDA Lifts U.S. Injunction on Philips’ Defibrillators
This business has been operating under a consent decree with the FDA since November 2017.Philips 04.24.20
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Diagnostics
FDA Clears Siemens Healthineers' Aidan AI
The latest technology enables new features and enhanced security.Siemens Healthineers 04.22.20
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Diagnostics
ELITechGroup MDx, OSANG Healthcare Receive Emergency Use Authorization for COVID-19 Test Kits
Test delivers qualitative results within hours.PR Newswire 04.20.20
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Surgical | Testing
Medical Robots: Assessing Safety and Performance in a Growing Field
Be aware of potential hazards robots may present and testing options to address them.Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
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Contract Manufacturing
Philips Partners with Flex, Jabil to Speed Hospital Ventilator Production
Philips hopes to manufacture 4,000 units per week by the third quarter.Philips 04.14.20
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COVID-19 is Exposing the Fragility of Global Supply Chains
Pandemic likely will prompt healthcare companies to reshape supply chains to strengthen the risk management process and resilience.GlobalData 04.13.20
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Machining & Laser Processing
New Methods 5-Axis Bridge-Type Machining Center Offers High Performance
Machine can perform full five-axis precision machining of challenging parts, significantly reducing the need for multiple setups.Methods Machine Tools 04.09.20
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Pentax Medical to Pay $43 Million Over Misbranded Endoscopes
Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.U.S. Department of Justice 04.08.20
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Diagnostics
Nova Biomedical Adds PT/INR Test to Allegro Analyzer
New PT/INR test are available now for purchase in CE regulated countries.Nova Biomedical 04.07.20
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3D/Additive Manufacturing
Materialise's 3D Printed Oxygen Mask Helps Ventilator Shortage
COVID-19 solution brought to hospitals quickly and in full compliance with safety regulations.Videos Materialise
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Mack Molding Names Vice President of Business Development
Company also has added positions and/or promoted workers in quality, business development, customer management, manufacturing, purchasing and human resources.Mack Molding 04.02.20
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Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic
A reminder of what manufacturers should keep in mind during this turbulent time.Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20
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R&D & Design
Examining the Usability of Medical Software
Developers need to consider the ‘human factor’ when it comes to testing medical device software.Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20
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The Challenge and Opportunity in Corporate Environmental Sustainability Efforts
One company shares its experiences and outcomes with ongoing efforts toward a focus on environmental stewardship.Neil Peterson, Alisha Jerauld, CPA and Matt Wold, Merit Medical Systems Inc. 04.01.20
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A Manufacturer’s Secret Weapon: R&D Tax Credits
For small and medium-sized medical device manufacturers, qualifying for the tax credits could result in an unexpected windfall.Chris Lake, President, R&D Tax Credit Consultant 04.01.20
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Software & IT
Validating Your QMS the ‘EZ Way’
Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.James Shore and Roxana Rosales 04.01.20
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Digital Health
Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools
Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.Michael Barbella, Managing Editor 04.01.20
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Tubing & Extrusion
Pathways to Care: Tubing Technologies
Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.Mark Crawford, Contributing Writer 04.01.20
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Testing
Plastikos and Plastikos Medical Implements ISO 14698
This system is dedicated to test for bio-contamination, and evaluate microbiological data.Plastikos 04.01.20
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Neil Tween Joins Owlstone Medical
Neil Tween appointed as Chief Financial Officer.Owlstone Medical 03.30.20
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Oxford and King’s Developing Prototype for Rapidly Deployable Ventilator
An interdisciplinary team of engineers and medics is addressing ways to increase the UK’s capacity for ventilator manufacture.03.20.20
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FDA Suspends Foreign Inspections
The agency has postponed most foreign inspections through April, effective immediately.Food and Drug Administration 03.10.20
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Digital Health
Teamplay Digital Health Platform Launched by Siemens Healthineers
The teamplay digital health platform facilitates easy access to solutions for operational, clinical, and shared decision support.Siemens Healthineers 03.09.20
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Diagnostics
LabCorp Launches COVID-19 Diagnostic Test
For use by clinicians with patients who meet COVID-19 evaluation criteria.Business Wire 03.06.20
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Cardiovascular
Trial Data Reaffirms Safety Profile of Philips Stellarex Drug-Coated Balloon
Mortality rates similar to standard of care through four years with excellent rate of follow-up compliance.Royal Philips 03.06.20
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FDA Approves Allergan's Durysta Glaucoma Implant
Lowers intraocular pressure in patients with open-angle glaucoma or ocular hypertension.PR Newswire 03.06.20
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R&D & Design
Four Considerations for Developers of Next-Generation Combination Products
Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20
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Software & IT
Realizing Production Efficiency Through ERP Solutions
Medical product outsourcers share insights and best practices through a survey of manufacturers that’s centered around their outlook for 2020.Louis Columbus, Principal, IQMS/DelmiaWorks 03.04.20
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Testing
Testing in Flux: Changing Protocols for a Transformative Industry
As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.Mark Crawford, Contributing Writer 03.04.20
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Contract Manufacturing
The Seychelles—A Solution for Niche Production
Geographic location, free trade agreements, and an educated workforce make the location an excellent fit for the right manufacturer.Jude Shroff, Managing Director, Chelle Medical Ltd. 03.04.20
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Class Ir Device Manufacturers Must Keep Their Feet on the Gas
The recent deadline extension for Class I reusable devices to comply with MDR is a relief, but these next four years will go by fast.Dan Fowler, Principal Scientist, WuXi Medical Device Testing 03.04.20
