Medical Product Outsourcing

Neurological

Q’Apel Medical Inc. Receives CE Mark for Walrus Balloon Guide Catheter

The Walrus BGC has been utilized by Neuro Interventional physicians since 2019 and has successfully treated over 20,000 patients in the United States.

Charles Sternberg, Associate Editor 03.28.23

physIQ’s eVO2Max Can Estimate Cardiopulmonary Functional Capacity From Sensor Data

Approach can deliver cardiopulmonary exercise test results comparable to gold-standard testing with a wearable sensor during routine daily activities.

Michael Barbella, Managing Editor 02.24.23

Dharmesh Patel Appointed VP of QA and RA at EMMA International

New hire has more than 25 years of experience in quality assurance and regulatory affairs, with the past 12 years spent at the FDA.

Michael Barbella, Managing Editor 11.18.22

Cardiovascular

Qardio Releases RPM Solution Featuring a Cardiac Monitoring Service

QardioDirect now includes ambulatory cardiac monitoring to help diagnose atrial fibrillation along with various other arrhythmias.

PR Newswire 12.14.21

Cardiovascular

Qardio Names Medtronic Exec Mike Alvarez as President, CEO

Brings significant experience in cardiac and remote patient monitoring.

Sam Brusco, Associate Editor 12.02.21

Digital Health | Patient Monitoring

Qardio Releases Remote Patient Monitoring and Telehealth Service

QardioDirect is an all-inclusive service for RPM that works seamlessly with both patient and doctor.

PR Newswire 11.18.21

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

An Industry Study Guide for BIMO FDA Inspections

If the thought of a BIMO inspection makes you break into a cold sweat, check out this set of guidelines.

Online Exclusives Brandy Chittester, MS, CCRA, President, IMARC Research 03.02.20

Software & IT

The True Cost of Paper

Rethinking your approach to quality management.

Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 02.13.20

Software & IT

Six Mistakes to Avoid When Implementing ISO 13485

Ditching the checkbox mentality and last-minute scrambles.

Online Exclusives Jon Speer, founder and VP of QA/RA at Greenlight Guru 01.20.20

5 Tips to Raise Investor Interest and Fund Your Medical Device

Make your startup more attractive to investors.

Online Exclusives Jon Speer, Founder of Greenlight Guru 01.15.20

Software & IT

Survey Identifies Challenges to Improving Product Development Processes

81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.

PRWeb 11.26.19

Diagnostics | Software & IT

5 Takeaways from RAPS Convergence 2019

The medical device regulatory landscape is changing faster than ever and we need to keep up.

Online Exclusives Deborah Pinchev, QA/RA Manager, StarFish Medical 10.31.19

MPO Summit 2019 Conference Program Notebook

An ongoing update of MPO Summit 2019 sessions.

Online Exclusives Michael Barbella, Managing Editor 10.03.19

Digital Health | Software & IT

Nova Leah Achieves ISO 27001 and ISO 9001

Cybersecurity solutions provider for medical device manufacturers was awarded certifications by the NSAI.

Nova Leah 09.25.19

28. Varian

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07.30.19

Cardiovascular | Contract Manufacturing | Electronics | Molding | Patient Monitoring

Staying Dry: Waterproofing a Heart Monitor

Comar resolves market growth needs for the myPatch sl Holter recorder while enhancing design and addressing specific demands.

Online Exclusives Adrian Possumato, Principal Consultant, Medica Consulting 05.21.19

The Quest for Cake: Leveraging Quality as a Business Partner

The quality function is not only about maintaining compliance; rather, real-world savings can be realized through its adherence.

Paul Robinson, Vice President of Operations, Quality Systems Consulting Services (QSCS) 04.03.19

Software & IT

Hand-in-Hand with Quality and (Regulatory) Changes

Greenlight Guru’s founder speaks with MPO about the firm’s FDA-connected initiatives and the changing regulatory landscape.

Online Exclusives Sean Fenske, Editor-in-Chief 04.03.19

Software & IT

It’s Time to Embrace Customer Centricity

In order to stay competitive, companies need to employ a customer-centric strategy to ensure success and relevance in 2019 and beyond.

Allyssa Eclarin and Ray Hein, Propel 03.07.19

MEDICAL DEVICE COMPANIES NEED TO EMBRACE CUSTOMER-CENTRICITY

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Nemaura Signs License and Distribution Agreement for SugarBEAT Commercial Launch in Qatar

The country has one of the world’s highest prevalence of diabetes.

Globe Newswire 01.07.19

Diagnostics | Surgical

Past Dues: Medtech's 2018 Year in Review

The industry confronted old ghosts in 2018 as it defended itself against a documentary and crammed for regulatory changes.

Michael Barbella, Managing Editor 11.26.18

Software & IT

6 Best Practices for Complying with ISO 13485:2016

At this stage, companies have less than six months to be compliant.

Online Exclusives Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 10.17.18

R&D & Design | Software & IT

5 Reasons Design Controls and Risk Management Processes Fail

Design controls do not have to be the big, imposing task they are often made out to be.

Online Exclusives Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 08.20.18

Patient Monitoring

FDA Clears Baxter's Spectrum IQ Infusion System with Dose IQ Safety Software

New features include bi-directional electronic medical records integration, auto-programming, and auto-documentation.

PR Newswire 05.14.18

Will Regulatory Transitions Cause Some to Change Course?

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Sean Fenske, Editor-in-Chief 04.03.18

Matrix Plastic Products Celebrates 40th Anniversary

Medical molder and moldmaker couples milestone with rebranding.

Matrix Plastic Products Inc. 03.19.18

Software & IT

Software Solution Streamlines Post-Market Quality Processes

eQMS specifically for medical device will enable companies to move beyond baseline compliance to true quality.

Greenlight Guru 10.30.17

Proper Design Controls Could Save You $20 Million

Considerations for smaller medical device companies to avoid potentially damaging deficiencies during product development.

Online Exclusives Jon Speer, Founder and VP of QA/RA, greenlight.guru 09.07.17

Testing

Discussing the UL/Emergo Merger: A Q&A

Representatives from both firms speak about the transaction, the expected benefits, and what’s ahead.

Online Exclusives Sean Fenske, Editor 06.20.17

Testing

Software & IT

R&D & Design

FDA Approves Connected Blood Pressure Device From Qardio

App for iOS and Android connects with wearable monitor to record blood pressure.

10.16.14

FDA OKs Wireless Blood Pressure Monitor from Qardio

The device, sold directly to consumers, is designed to be attractive and unobtrusive.

06.25.14

R&D & Design

Orchid Design’s QA/RA Team Expands in Size and Talent

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06.10.14

R&D & Design | Testing

Orchid Design's QA/RA Team Expands in Size and Talent

Firm adds new associate and current staff certifications.

05.29.14

Cardiovascular | R&D & Design

Intact Vascular Names RA/QA VP

New hire comes from JNJ's Cordis division.

02.27.14

Contract Manufacturing | R&D & Design

Resonetics Names QA/RA Director

New hire brings years of quality and regulatory experience.

12.11.13

Insulet Hires New QA Executive

The new VP comes with experience in diabetes devices.

Niki Arrowsmith 01.23.13

Contract Manufacturing

Ram Precision Industries Brings on New QA Manager

New hire has more than 24 years of experience.

Contract Manufacturing | R&D & Design

MRI Medical Names New RA/QA Director MRI Medical has added a Regulatory Affairs and Quality Assur

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10.12.10

Contract Manufacturing | Materials | R&D & Design | Software & IT

Industry QA: Outsourcing vs. Offshoring

A group of industry insiders shares thoughts on the definition of outsourcing, where the overlaps are, misperceptions and ways medical device companies distinguish between the two.

Christopher Delporte 03.04.09

Contract Manufacturing | Molding | Tubing & Extrusion