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PhysIQ Elects Former Naval Vice Admiral to its Advisory Board
New board member most recently Washington State's medical and healthcare systems response to the COVID-19 pandemic.Business Wire 01.21.21
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Contract Manufacturing
Vonco Products Receives ISO 13485:2016 Certification
Both a packaging company and a components company, Vonco started as a custom equipment and packaging pioneer.Business Wire 01.12.21
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Highly Flexible UV Curable Adhesive Meets ISO 10993-5 Standard for Cytotoxicity
Product: UV15X-6Med-2LV
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Foldax Strengthens its Scientific and Medical Advisory Boards
Company adds two new members to each of the governing bodies.Business Wire 11.17.20
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HeartHero Inc. Awarded ISO 13485 Certification
Company to continue regulatory path for AED in collaboration with the American College of Cardiology.Business Wire 11.05.20
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Optikos Receives ISO 13485:2016 Certification
The company provides both optical engineering and volume manufacturing services.Business Wire 10.21.20
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Surgical
ExplORer Surgical Appoints Senior Advisor
Adds new member to board of directors.ExplORer Surgical 10.15.20
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Digital Health | Software & IT
GE Healthcare Introduces Edison HealthLink
New edge technology is designed to give clinicians rapid access to critical data.PR Newswire 10.14.20
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INSPECTIS Achieves ISO 9001 Certification
The certification reinforces the company's commitment to quality management.INSPECTIS AB 10.06.20
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Clarius Appoints Medical Advisory Board Chairman
New leader will support the company's R&D team to ensure ultrasound devices are optimally designed for various specialities.PR Newswire 09.30.20
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Testing
Nelipak Facility Earns ISO/IEC 17025 Accreditation
Provides a comprehensive range of testing services to support package testing requirements.Nelipak 09.10.20
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INSPECTIS Achieves ISO 13485 Certification
The company designs and produces digital optical microscopes.INSPECTIS AB 09.01.20
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Performance Motion Devices Receives ISO 13485 Certification
Demonstrates its commitment to process and quality control.Performance Motion Devices Inc. 08.25.20
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Materials
Peak Performance Compounding Achieves ISO 13485:2016, 9001:2015 Certifications
ISO certifications achieved for toll processing and formulation of thermoplastic compounds for the medical and industrial markets.Peak Performance Compounding 08.18.20
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Mike on Medtech: 50th Episode—A Look Back
Mike Drues and Sean Fenske look back at the previous 49 episodes and highlight a variety of topics covered in this anniversary episode.Sean Fenske, Editor-in-Chief 08.10.20
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Materials
Peak Obtains ISO 13485:2016 and 9001:2015 Certifications
Offers toll processing and custom formulations for the medical and industrial markets.Peak Performance Compounding Inc. 08.04.20
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Sommetrics Receives ISO 13485:2016 Certification
Company can now pursue HealthCanada for market clearance of the aerSleep device.Business Wire 07.20.20
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3DEO Achieves ISO 9001:2015 Certification
The certification took three months, roughly half the average time it takes for conventional implementation.3DEO 07.17.20
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Morepen Laboratories Receives ISO-13485 Certification For its Baddi Facility
The plant manufactures blood glucose meters, blood glucose testing strips, blood pressure monitors, thermometers, pulse oximeters, and other devices.Morepen Laboratories 07.06.20
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Stanford University Professor Named Clinical Advisor at Spry Health
Appointment reflects Spry’s commitment to expanding remote patient monitoring protocols and clinical pathways.Business Wire 06.12.20
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MediPines Corporation Achieves ISO 13485 Certification
Company manufactures portable respiratory devices designed to provide real-time, clinically actionable data.PR Newswire 06.08.20
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Universal Photonics Achieves ISO 9001:2015 Certification
Company's Central Islip, N.Y., facility joins its already-certified Vernon, N.Y., facility, creating a comprehensive ISO 9001:2015 certified operation.Universal Photonics Inc. 06.05.20
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ISO 13485 Remote Audits: Views from Both Sides of the Table
Remote audits have been a standard practice for low-risk suppliers or in the cases where restrictions existed in entering certain parts of the world.Jim Shore, Quality Lean Solutions, and Neel Patel, Florida Anodize System & Technologies 06.04.20
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Ocutrx Eyes Telemedicine Market With Advisory Boards Appointment
New board member will serve as a visionary for the company as it moves forward with new innovations in medical data, artificial intelligence, and telemedicine.Ocutrx Vision Technologies LLC 06.01.20
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H&H Machining Center Awarded ISO 13485 Certification
Company's expertise areas include DFM, medical device R&D, reverse engineering, and prototyping, among others.Business Wire 05.20.20
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The Medtech Supply Chain and COVID-19
How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?Online Exclusives Sean Fenske, Editor-in-Chief 04.22.20
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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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HeartVista Forms Medical and Scientific Advisory Board
Governing body comprised of leaders from Stanford University and the University of Wisconsin.Business Wire 04.16.20
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Agiliti Acquires Mobile Instrument Service & Repair
Deal expands and extends Agiliti’s clinical equipment service offering.Business Wire 04.15.20
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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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Stroke Care Expert Joins Ischemia Care Advisory Board as Chairman
Newest member has led or participated in numerous Phase II and III clinical stroke trials over the past 20 years.Business Wire 04.09.20
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Foster Corporation, LioChem Expand Medical Color Masterbatch Capability
Lioplax MD color masterbatch products, capability, and expertise will allow Foster to offer increased service levels and larger order capabilities.Foster Corporation 04.07.20
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Software & IT
Building a Medtech Firm on a Foundation of Quality
C2DX impresses auditors and breezes through an MDSAP audit after implementing a medical device QMS.Online Exclusives Nick Tippmann, VP of Marketing, Greenlight Guru 04.06.20
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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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Diagnostics
Co-Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Test
Company's technology targets the virus's RdRp gene.PR Newswire 04.06.20
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Polyzen Helps to Address Shortage of PPE
Commits to assist manufacturers, hospitals, and other healthcare facilities in getting the supplies they need.Polyzen 04.03.20
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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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Diagnostics
PCR Biosystems Works to Ensure Availability of COVID-19 Test Reagents
Company has the capacity to manufacture enough reagent daily for 4 million reactions, which is sufficient for millions of diagnostic tests.PCR Biosystems 04.02.20
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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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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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Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape
The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined.Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services 04.01.20
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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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Molding
GW Silicones Announces Fourth Expansion Since Inception
Contract manufacturer grows advanced silicone tooling and molding operation in Royalton, Vt.GW Plastics 03.12.20
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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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Materials
A Matter of Substance: Medical Device Materials
Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.Michael Barbella, Managing Editor 03.04.20
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Testing
The Importance of Usability/Human Factors Testing
When is the work of human factors over, and how does your team know they are prepared for summative testing?Maria Shepherd, President and Founder, Medi-Vantage 03.04.20
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