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Outsourcing Directory
ETQ
Company Headquarters
700 District Avenue
Suite 900
Burlington, MA 01803
United States
Outsourcing Directory
In-Vitro Diagnostic Categories
Content From ETQ
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EtQ Announces New Life Science Features in its Traqpath Product
EtQ today announced the addition of Life Science features in its Traqpath product.Product Releases Released on 12.15.2016
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Why Excluding Suppliers from Your Quality Processes Could Cost You
...Literature / Brochures Released on 04.26.2016
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The eMDR Requirement: Best Practices for Enhancing Collaboration with the FDA
...Literature / Brochures Released on 04.25.2016
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Steps to Implementing a Successful Employee Training Management System
...Literature / Brochures Released on 04.22.2016
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eMDR is Now Required: Learn the Benefits of Electronic Reporting
...Literature / Brochures Released on 04.21.2016
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Is Your Document Control System Effective? 8 Signs that It Is
...Literature / Brochures Released on 04.20.2016
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8 Traits of an Effective Corrective Action System
Key areas to Mitigate Risk in CAPA SelectingLiterature / Brochures Released on 04.19.2016
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GMP Compliance that Spans the Supply Chain
Considerations for Extending the Quality System Beyond Your EnterpriseWhite Papers / Tech Papers Released on 04.18.2016
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EtQ Reliance Cloud Portal Provides Proven Supply Chain Visibility for Customers
...Press Releases Released on 02.17.2016
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EtQ Merges VERSE Solutions™ to its Compliance Product Offerings
VERSE Incorporates Needs of Small to Mid-Sized Businesses into EtQ’s Diverse Product PortfolioPress Releases Released on 02.03.2016
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EtQ Launches Free Application for Event Tracking and Corrective Action; Cultivates Collaboration an
New App, traqpath™, Expands the Reach of Compliance to EveryonePress Releases Released on 01.27.2016
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Patient Monitoring
Survey: Patient Focus Breeds Success for Remote Cardiac Monitoring Programs
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Xenter Appoints Four Healthcare Industry Leaders to its Board
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Digital Health
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EU MDR Preparedness: How Is COVID-19 a Factor?
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R&D & Design
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Diagnostics
How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests
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Surgical
The Future of AI and OR Medical Devices
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Validant Acquires Greenleaf Health
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Patient Monitoring
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CeQur Raises $115 Million Series C5 Financing
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Contract Manufacturing
Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.Dale Thompson, Staff Writer, MasterControl 05.27.21
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Digital Health
Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology
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3M Unveils Silicone Adhesive for People With Fragile Skin
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Quidel Granted EUA to Market COVID-19 Antigen Test
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Contract Manufacturing
A Contract Manufacturer Selection Handbook
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FDA Grants Breakthrough Device Status to Epilepsy Treatment System
NeuroPace's RNS System is currently available in the United States as an adjunctive therapy for adults with drug-resistant focal epilepsy.Michael Barbella, Managing Editor 05.12.21
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Contract Manufacturing
Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A
A contract manufacturer should complement the OEM in every step of the product development process, from concept to commercialization.
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FDA Approves Helius Medical's Stimulator Device for Gait Improvement
The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.Michael Barbella, Managing Editor 05.06.21
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Preparing for the EU’s MDR
As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21
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Tubing & Extrusion
Demystifying Multi-Lumen Tubing—A Medtech Makers Q&A
MicroSpec’s Tim Steele shares his expertise on factors to consider when specifying multi-lumen tubing and also reveals common challenges he encounters.
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Electronics
OEMs Increasingly Choosing EMS Providers Closer to Home
Firstronic CEO notices preference among major device firms to reshore electronics manufacturing.Michael Barbella, Managing Editor 04.23.21
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Cardiovascular
Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology
Menlo Ventures, UCHealth invest to bring comprehensive hypertension measurement and management to the phone.Michael Barbella, Managing Editor 04.20.21
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Diagnostics
FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.Charles Sternberg, Assistant Editor 04.15.21
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Vicarious Surgical Appoints CFO and Chief Legal Officer
William J. Kelly and June M. Morris have joined the company's executive team.Michael Barbella, Managing Editor 04.14.21
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Cardiovascular
Elixir Medical Begins Study of Metallic Implant for CAD Treatment
Product is designed to adapt to vessel physiology.Michael Barbella, Managing Editor 04.13.21
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Software & IT
Three Future Trends and Opportunities in Quality Assurance
As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.David Jensen, Staff Writer, MasterControl 04.09.21
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Software & IT
Adopting a Data-Driven Quality Model
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Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use
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Molding | Surgical
Optimizing MIM in Medical Device Manufacturing
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Diagnostics
PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
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Testing
The Evolution of Chemical Characterization for Medical Devices
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Four Considerations When Selling to a Private Equity Fund
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Contract Manufacturing | Software & IT | Testing
Quality & Regulatory Solutions for the FDA Regulated Industries
EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.
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Diagnostics
BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing
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Software & IT
Using Quality as an Advantage in 2021
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Diagnostics
Optellum Receives FDA Clearance for Virtual Nodule Clinic
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Diagnostics
FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device
Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.Sam Brusco, Associate Editor 03.23.21
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Contract Manufacturing | Molding
Medtech Makers: Molding Validation Optimization
PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.
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Olympic Bobsledder Named New Board Chairman at PathogenX
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Software & IT
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Virginia School of Medicine Dean Appointed to Baxter's Board
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Reusable device validation
The medical industry is familiar with the use of autoclaves in operating rooms and laboratory settings for sterilization.
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Plastikos Medical Begins Phase II of Expansion
Will more than double the size of its current ISO-7 cleanroom.Charles Sternberg, Assistant Editor 03.03.21
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Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
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FDA Approves Daytime Treatment for Sleep Apnea and Snoring
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Trademark Plastics Inc. Partners with MedAccred
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Diagnostics
Study Validates Vocalis Health’s COVID-19 Screening Tool
VocalisCheck obtains CE mark approval for medical use.Charles Sternberg, Assistant Editor 02.18.21
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FDA Clears Pulse Biosciences' CellFX System
The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.Michael Barbella, Managing Editor 02.17.21
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Diagnostics
Medtech Matters: Hologic’s Breast Health Happenings
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Cardiovascular | Neurological
Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status
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Diagnostics
Avacta Group and Mologic Enter Commercial Partnership
Aims to accelerate to market Avacta’s SARS-CoV-2 antigen test and support testing in low and middle income countries.Charles Sternberg, Assistant Editor 02.08.21
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Contract Manufacturing
Use Vertical Integration to Increase Productivity, Drive Innovation
The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21
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Neurological
Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis
New study shows promising efficacy and safety profile for novel ‘e-mmunotherapy’ approach to disease treatment.Charles Sternberg, Assistant Editor 02.02.21
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Stericycle Settles Environmental Violations at Its Medical Waste Incinerator
Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.Michael Barbella, Managing Editor 02.01.21
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Patient Monitoring
Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech
EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.Sam Brusco, Associate Editor 02.01.21
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Kwivik Therapeutics, EirMed Partner to Accelerate Product Commercialization
Kwivik has developed a pipeline of products for certain respiratory, emergency medical, asthma, migraine/cluster headache, wound care, and skin care markets.Michael Barbella, Managing Editor 01.27.21
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MedAcuity, Fathom Partner on Human Factors Engineering Services
Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.Michael Barbella, Managing Editor 01.25.21
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Are you prepared for EUDAMED actor registration module? Let’s get started
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Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection
The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.Michael Barbella, Managing Editor 01.22.21
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TPI Partners with Zeiss
Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.Charles Sternberg, Assistant Editor 01.21.21
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MGS Acquires Formteknik
Expands the MGS team to 1,500 employees, with 11 facilities globally.MGS 01.08.21
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Greenlight Guru and Nelson Labs Partner
Alliance helps customers mitigate risk and go to market faster.Greenlight Guru 01.06.21
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Packaging & Sterilization | Surgical
Olympus Releases ScopeLocker Endoscope Storage Cabinet
HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.Olympus 01.06.21
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Diagnostics
Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval
Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.Mologic Ltd 01.05.21
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Preparing Your Design Controls for FDA Approval
Design controls are a set of procedures to build into medical device design and development.Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20
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Survey Finds On-Site Inspections Plummeted by 93 Percent
Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.Greenlight Guru 12.08.20
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Digital Health
Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20
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Molding
Tooling Precision is Key to Micromolding Success
Tool quality dictates part quality for all sizes of medical components.Michael Barbella, Managing Editor 12.03.20
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Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon
No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.Royal Philips 12.03.20
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Cardiovascular
VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution
Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.Business Wire 11.23.20
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THE DETROIT FREE PRESS NAMES PTI Engineered Plastics
A WINNER OF THE DETROIT TOP WORKPLACES 2020 AWARD
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Molding
Miniaturization of Medical Devices Creating Big Assembly Challenges
Extremely tight tolerances leave no room for error.Michael Barbella, Managing Editor 11.20.20
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Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation
aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.Business Wire 11.17.20
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FDA Agrees to Participate in MDIC's Collaborative Community Initiative
Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.Business Wire 11.17.20
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R&D & Design
How Design Controls Can Prevent Medical Device Recalls
Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20
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Indago Appoints President and General Counsel
New leader has 15 years of experience in the life sciences industry.Business Wire 11.16.20
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Diagnostics
QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test
Can accurately analyze over 30 samples per hour.Business Wire 11.12.20
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Patient Monitoring
Prevounce Health Launches Remote Patient Monitoring Module
The module combines digital spirometry, smart nebulizers, and pulse oximetry.PR Newswire 11.10.20
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R&D & Design
Medtech Makers: Collaborating with Full-Service Design and Development Providers
Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.
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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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Chronic Disease
Pharmaceutical Focus: A Look at Combination Products
Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.Mark Crawford, Contributing Writer 11.04.20
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3D/Additive Manufacturing
The Printed World: Additive Manufacturing in Medtech
Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.Sam Brusco, Associate Editor 11.04.20
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Quality Assurance When Supply Chain Disruptions Arise
From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
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GLEAMER Raises 7.5 Million Euros to Develop AI Radiology Product Line
Company is seeking FDA clearance of its traumatic injury detection tool.GLEAMER 11.03.20
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Diagnostics
Imec Developing Five Minute COVID Test
Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.Imec 10.30.20
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Summit Medical, Practico Solutions Develop Tracking Module for Robotic Instrument Reprocessing
Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.Business Wire 10.22.20
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Electronics
Connected Health Driving Demand for Comprehensive Electronics Solutions
Medical electronics must be designed to handle the increased bandwidth, high-speed interconnects inclusive of fiber optics, and high signal integrity and speed.Michael Barbella, Managing Editor 10.09.20
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Contract Manufacturing | Electronics
Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers
But many companies are hesitant to start new development projects while the coronavirus is still rampant.Michael Barbella, Managing Editor 10.05.20
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Sensera Achieves ISO 13485 Quality Certification
The company previously achieved ISO 9001:2015 certification in 2017.Business Wire 11.06.18
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3D/Additive Manufacturing | Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Software & IT | Surgical
The Top 10 Medical Innovations for 2019
A panel of top doctors and researchers presents the advancements with the power to transform healthcare in 2019.Cleveland Clinic
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Professional Development for the Quality/Regulatory Professional
...James A. Dunning, Principal, QPC Services LLC 10.16.18
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Contract Manufacturing
Automating the Manufacturing Orchestra
Sophisticated welding tools, robotic systems, DFM, and Industry 4.0 address medtech assembly challenges.Mark Crawford, Contributing Writer 10.16.18
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Cardiovascular | Machining & Laser Processing | Neurological | Surgical
Resonetics and Meraqi Medical Announce Strategic Alliance
Collaboration between leading development and manufacturing experts to reduce time-to-market.Resonetics 10.04.18
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Motus GI Appoints Vice President of U.S. Sales and Commercial Operations
New hire brings extensive background in innovative GI product sales and will lead development.Business Wire 09.14.18
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Cardiovascular
In Sync: A Review of Cardiac Rhythm Management Technologies
An aging world population and improved treatments for faulty heartbeats are driving growth in the global CRM market.Michael Barbella, Managing Editor 09.07.18
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Machining & Laser Processing | Software & IT
LaVezzi Precision Achieves ISO 13485:2016 Certification
The company has demonstrated its quality management system consistently provides products meeting requirements.LaVezzi Precision 08.31.18
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Contract Manufacturing
Orchid Creates Innovation and Product Quality Organization
With 20 years of experience in R&D and operations roles in medtech, Ted Bloomfield will lead the organization.Orchid Orthopedic Solutions 08.22.18
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Masimo and PositiveID Announce the U.S. Release of TIR-1
The clinical-grade infrared thermometer provides forehead temperature measurements across all patient populations.Business Wire 07.30.18
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Molding
Mack Molding Adds to Top Level Staff
Company appoints human resources and IT directors.Mack Molding 06.12.18
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Diagnostics
Mologic Signs Agreements with Medisur and Peripal to Distribute PERiPLEX POC Diagnostic in Europe
Point-of-care test for detection of infection in dialysis patients available in a half-dozen countries.Mologic Ltd. 06.05.18
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Software & IT
Digitalization of the QMS: 15 Years of Evolution
...Alexa Sussman, Content Marketing Writer, EtQ 06.04.18
