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How to Become ISO 13485 Certified
Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.Online Exclusives Emily Drinks, Digital Content Consultant with WebFX 08.05.21
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FDA Grants IDE Approval for Zoll's ISO Shock Feasibility Study
Trial to evaluate the safety and feasibility of TherOx Supersaturated Oxygen therapy in STEMI patients presenting with cardiogenic shock.Business Wire 07.15.21
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NORBIT Achieves ISO 13485 Certification
The certification allows the Norwegian electronics supplier to service the medical industry.NORBIT 06.30.21
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Patient Monitoring
'Invisible Sensor' Supports World-First Sleep Disorder Trial
Researchers will test Sleeptite's non-invasive sensor monitoring technology, REMi.RMIT University 06.30.21
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Digital Health | Software & IT
GE Healthcare, Wayra Choose 5 AI-Led Startups for Edison Accelerator
Provides world-class clinical, technical, and commercial mentorship to EMEA-based start-ups.GE Healthcare 06.25.21
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David C. Klonoff Appointed to Integrity Applications Scientific Advisory Board
New chairman was the lead investigator for the first randomized controlled multicenter trial of an outpatient artificial pancreas product.Globe Newswire 06.17.21
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Aptar CSP Technologies Earns ISO 13485 Certification
Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.Aptar CSP Technologies 06.14.21
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Diagnostics | Neurological | Software & IT
FDA OKs Autism Spectrum Disorder Diagnostic Aid
Cognoa ASD Diagnosis Aid uses a machine learning algorithm to evaluate patients at risk of ASD.Sam Brusco, Associate Editor 06.03.21
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nanoComposix Achieves ISO13485:2016 Certification
Company recently expanded its manufacturing capability for large-scale production of 40 nm gold nanoparticles.Michael Barbella, Managing Editor 05.20.21
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Iterative Scopes Announces IBD-Focused Scientific Advisory Board
The governing body also will include experts in artificial intelligence.Michael Barbella, Managing Editor 04.16.21
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Nagarro Achieves ISO 13485 Certification
Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.Michael Barbella, Managing Editor 04.14.21
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Philips Names New Supervisory Board Chairman
Company is adding two new members to the board, and reappointing its chief legal officer to the Board of Management.Michael Barbella, Managing Editor 03.12.21
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Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation
Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.03.04.21
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Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
Meet the highest quality standards for manufacturing.Charles Sternberg, Assistant Editor 02.25.21
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Investment Advisor Joins Ra Medical's Board
New member has more than 20 years of experience advising corporate clients and their boards.Michael Barbella, Managing Editor 02.22.21
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New Chairman Named for Ocutrx International Scientific Advisory Board
Leader is a co-founder and managing director of Versant Ventures.Michael Barbella, Managing Editor 02.05.21
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Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions
The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.Michael Barbella, Managing Editor 01.29.21
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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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