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mdsap
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ExThera Medical Gains MDSAP Certification, ISO 13485 Recertification
The dual certification enables commercial pathways for extracorporeal procedures to treat bloodstream infections and metastatic pancreatic cancer.
Michael Barbella, Managing Editor
10.20.23
Neuronetics Granted MDSAP, CE Mark Certification Under New MDR
MDSAP certification covers distribution in five countries, including the U.S., Japan, Canada, Australia, and Brazil.
Michael Barbella, Managing Editor
07.11.23
Sanmina Achieves MDSAP Certification at Facilities in Malaysia, Singapore, Sweden
The certification reduces regulatory risk during medical device manufacturing.
Sanmina Corporation
07.09.20
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
NSF International EVP Appointed to RAPS Board
Kim Trautman joins the board.
NSF International
01.28.20
Diagnostics
|
Digital Health
|
Surgical
Sounding Board: Looking Back at 2019 and Gazing at 2020
MPO editorial advisory board members share their thoughts on the most significant events of 2019 and what they expect to watch in 2020.
Online Exclusives
Sean Fenske, Editor-in-Chief
12.10.19
MPO Summit 2019 Conference Program Notebook
An ongoing update of MPO Summit 2019 sessions.
Online Exclusives
Michael Barbella, Managing Editor
10.03.19
Contract Manufacturing
|
Digital Health
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Software & IT
Connecting the Dots in Medical Device Outsourcing
...
MPO Staff
07.30.19
RIMSYS Regulatory Management Software Forms Advisory Board
The board members will serve as strategic partners in the company's continued development.
Business Wire
05.22.19
Cardiovascular
Bardy Diagnostics Expands Into Canadian Market With Distributor JNC Medical
Partnership strengthens BardyDx's international distribution and business development initiatives.
PR Newswire
04.12.19
iSchemaView’s RAPID Approved for Use in Brazil
Company expands RAPID’s South American footprint by bringing Brazil a next-generation imaging platform for assessing ischemic stroke.
Business Wire
04.05.19
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
Three Questions to Master Continual MDSAP Conformity
...
Tony Parise, Product Strategist—Life Sciences, ETQ
03.07.19
ivWatch Extends Patient Monitor to International Markets
Company signs an agreement with New Medical.
Business Wire
01.02.19
MDR Insight: How to Strategize for CER Success
A sound plan for success can provide companies a competitive advantage and keep existing products on the market.
Online Exclusives
Scott Edwards, Managing Director, Solutions Delivery, Maetrics
12.18.18
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
The Regulatory Outlook for 2019
...
James A. Dunning, Principal, QPC Services LLC
11.26.18
Software & IT
Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS
...
Annette Schaps, Schaps Consulting, and Chuck Cimalore, Arena Solutions
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
Contract Manufacturing
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Molding
|
Testing
MPO Summit 2018 Conference Program Notebook
An ongoing update of MPO Summit 2018 sessions.
Online Exclusives
Michael Barbella, Managing Editor
10.11.18
ivWatch Receives CE Mark for the ivWatch Model 400
Recent regulatory approvals and global certification pave the way for international distribution.
Business Wire
10.04.18
iSchemaView’s RAPID Approved for Use in Canada
Decision gives Canadians access to the only clinically validated, next-generation imaging platform for assessing treatment.
Business Wire
09.19.18
Software & IT
How to Choose the Right Quality Management System
...
Chuck Cimalore and Rasean Hamilton, Omnify Software and EarLens
09.07.18
Taking Stock of MDR Compliance
Just over a year in since the new regulations were rolled out and companies are lagging well behind in meeting them.
Online Exclusives
Peter Rose, Managing Director—Europe, Maetrics
08.23.18
NSF International Launches Online Training on Medical Device Regulations for MDSAP Countries
Online learning modules prepare regulatory compliance officers, auditors for the Medical Device Single Audit Program.
NSF International
06.18.18
The ISO 13485:2016 Transition Journey
Results of an ASQ Biomedical Division survey on the move to the new standard are shared.
Jim Shore, Chair-Elect, ASQ Biomedical Division
06.04.18
15-Year Anniversary: A Reflection on Industry Changes Over MPO's Lifetime
MPO’s Editorial Advisory Board reflects on 15 years of outsourcing and the medtech industry as a whole.
Michael Barbella, Managing Editor
06.04.18
NSF Health Sciences Certification Expands Medical Device Certification Team
New appointee has over 10 years of experience in the international medical device and pharmaceutical regulatory field.
NSF International
04.13.18
Will Regulatory Transitions Cause Some to Change Course?
...
Sean Fenske, Editor-in-Chief
04.03.18
Software & IT
How an Automated QMS Helps to Keep Up with Regulatory Changes
...
Alexa Sussman, Content Marketing Writer, EtQ
03.15.18
Preparing for Medical Device Single Audit Program (MDSAP) Audit Success
...
03.15.18
NSF International Adds Former U.S. Regulator to Medical Device Certification and Training Program
FDA veteran tapped as executive director of Medical Device Certification and Training.
NSF International
02.15.18
NSF Health Sciences Certification LLC Receives Authorization as Auditing Organization for MDSAP
Demand for MDSAP audits expected to increase as Canada begins requiring MDSAP audits for products sold after Jan. 1, 2019.
NSF International
02.08.18
Act Now to Prepare for MDSAP Audits
...
Kim Trautman, Executive Vice President of Medical Device International Services, NSF International
01.29.18
NSF International Expands Medical Device Consulting Services in Europe With Purchase of PROSYSTEM AG
Deal diversifies NSF’s medical device service offerings and provides greater access to Europe's medtech industry.
NSF International
10.23.17
Webinar: Exploring the Medical Device Single Audit Program (MDSAP)
...
10.06.17
MDSAP: Its Value to Your Business and How to Adhere
Benefits gained from compliance with this program outweigh the additional challenges encountered at the onset.
Online Exclusives
Peter Rose, Managing Director Europe, Maetrics
09.12.17
NSF Health Sciences Certification Applies to Become MDSAP Auditing Organization
Application is a response to increased demand for Medical Device Single Audit Program audits.
NSF Health Sciences Certification LLC
07.27.17
NSF Health Sciences Certification Applies to Become MDSAP Auditing Organization
Application is a response to increased demand for Medical Device Single Audit Program audits.
NSF International
07.13.17
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
Four Takeaways from Recent Regulatory Audit Changes
...
Alexa Sussman, Content Marketing Writer, EtQ
05.01.17
UL Achieves Transition Accreditation for ISO 13485:2016
Medical device customers can now receive audits and certificates to standard to align with global regulatory requirements.
Underwriters Laboratories
03.30.17
Electronics
|
Patient Monitoring
Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
Product is the only device of its kind legally available without a prescription in the United States.
Capillus LLC
02.21.17
Contract Manufacturing
Capillus Laser Therapy Receives Medical Device License Approval in Canada
Company becomes first laser therapy cap manufacturer to be cleared by Health Canada.
Capillus LLC
11.08.16
Contract Manufacturing
|
R&D & Design
Capillus Earns ISO 13485 Certification Through Single Audit Program Pilot
Company is among the first to receive certification through the program.
Capillus LLC
09.28.16
Breaking News
GE HealthCare Rolls Out New AI-Powered Ultrasound for Women's Health
Otolith Labs Expands Leadership Team
AtriCure Rolls Out cryoSPHERE+ Probe for Post-Op Pain Management
Patient Enrollment Complete in Study of Route 92 Medical's HiPoint Reperfusion Catheters
Boston Scientific Has a Class I Embolization Tech Recall
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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