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WE INTERPRET THE LATEST MEDICAL DEVICE NEWS and REGULATORY UPDATES SO YOU DON’T HAVE TO

Clinical , IVD
June 16, 2020
IVD Clinical Trials in the Era of COVID-19: Time to go Virtual?
Nko Essiet
By: Nko Essiet
Industry Reposts
June 1, 2020
PharmTech Outlook: Cover Story Featuring NAMSA President & CEO, John Gorski
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Regulatory
April 9, 2020
European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)
By: Matt Royle
European Market , Regulatory
April 3, 2020
EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions
By: Matt Royle
FDA , Regulatory
March 5, 2020
FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions
By: Angela Mallery
FDA , Regulatory
February 27, 2020
U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process
By: Dennis H. Crane
Clinical , IVD
February 12, 2020
Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
By: Lillian Li
Asian Market , Regulatory
January 26, 2020
Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act
By: Takashi Tanaka, PhD, RAC
European Market , Quality , Regulatory
December 30, 2019
Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
By: Richard Bassett
FDA , Regulatory
December 3, 2019
The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval
By: Melissa_Cadaret
European Market , Regulatory
November 27, 2019
MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
By: Adrian Keene
European Market , IVD , Regulatory
November 18, 2019
Key Requirements of Post-Market Surveillance under IVDR
By: Warren Jameson
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren Jameson
European Market , Medical Device Testing , NAMSA Press Release
October 7, 2019
NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Clinical , European Market , Regulatory
October 2, 2019
MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
By: Dr. Vincent Legay
Asian Market , Regulatory
August 26, 2019
Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Quality , Regulatory
July 10, 2019
EU IVDR: Understanding the New QMS Requirements
By: Warren Jameson
NAMSA Press Release
June 11, 2019
NAMSA Recognized as Leading Medical Device CRO for Third Consecutive Year by Life Science Leader
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Clinical , IVD
June 4, 2019
Three Essentials for Smart IVD Clinical Trial Design
By: Ben Brown, PhD
FDA , Regulatory
May 30, 2019
FDA CDRH: New Organizational Structure Effective May 1, 2019
By: Richard Kotz, Senior Product Development Strategist
European Market , Regulatory
March 20, 2019
Draft Corrigenda for EU MDR and IVDR Released
By: Adrian Keene
European Market , Regulatory
March 6, 2019
EMA Issues Q&A Regarding Impact of MDR, Article 117
By: Adrian Keene
European Market , Regulatory
February 4, 2019
EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
By: Adrian Keene
European Market , Regulatory
January 25, 2019
UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
By: Adrian Keene
European Market , Regulatory
January 15, 2019
EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
By: Adrian Keene
European Market , Regulatory
January 10, 2019
Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
By: Stephan Buttron
NAMSA Press Release , Reimbursement
January 7, 2019
NAMSA Announces Acquisition of Reimbursement Strategies, LLC, Expands Medical Device Development Portfolio
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
FDA , Regulatory
November 28, 2018
FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program
By: Richard Kotz, Senior Product Development Strategist
Asian Market , NAMSA Press Release
November 19, 2018
NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Clinical , NAMSA Press Release
October 30, 2018
NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Regulatory
October 17, 2018
EU Commission & MDCG Release New MDR & IVDR Guidance Documents
By: Adrian Keene
FDA , Regulatory
September 11, 2018
FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?
By: Richard Kotz, Senior Product Development Strategist
Medical Device Testing , NAMSA Press Release
August 27, 2018
NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Quality , Regulatory
August 15, 2018
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
By: Stephan Buttron
FDA , Regulatory
July 30, 2018
FDA Announces FY19 User Fees
By: Barbara Atzenhoefer
European Market , Regulatory
July 26, 2018
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
By: Dr. Vincent Legay
IVD , NAMSA Press Release
July 11, 2018
NAMSA® Launches “Uniquely IVD” Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
FDA , Regulatory
June 21, 2018
Mid-Year FDA Regulation & Guidance Review
By: Kristy Katzenmeyer-Pleuss
FDA , Regulatory
June 11, 2018
FDA Issues New Draft Guidance Document for Pre-Submissions
By: Dennis H. Crane
Clinical , European Market , Regulatory
May 17, 2018
EU MDR and IVDR Compliance Planning Resources
By: Barbara Atzenhoefer
NAMSA Press Release
May 15, 2018
NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Regulatory
April 24, 2018
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
By: Stephan Buttron
Asian Market , Regulatory
April 4, 2018
Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , NAMSA Press Release
February 28, 2018
NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Asian Market , Clinical , Regulatory
February 21, 2018
CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices
By: Yufei Bai
European Market , Regulatory
February 8, 2018
EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
By: Adrian Keene
European Market , Medical Device Testing
February 1, 2018
NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
FDA , Regulatory
January 23, 2018
Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings
By: Angela Mallery
Quality , Regulatory
January 8, 2018
ISO 13485:2016 – Effective Preparation and Implementation of Medical Device Quality Management Systems
By: Darci Diage
Asian Market , Regulatory
November 28, 2017
CFDA Releases “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft
By: Yufei Bai
Asian Market , Regulatory
November 14, 2017
Japan’s “Ninsho Kijun” Regulatory Approval Pathway
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , NAMSA Press Release
October 30, 2017
NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Regulatory
October 27, 2017
Brexit and the Impact on UK Medical Device Operations
By: Katie Foskett
Quality , Regulatory
October 9, 2017
The Importance of Human Factors & Usability Engineering in Medical Devices
By: Stephan Buttron
Medical Device Testing
September 27, 2017
Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines
By: Anney N. Majewski
European Market , Regulatory
September 19, 2017
UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
By: Stephan Buttron
Asian Market , Regulatory
September 13, 2017
New Medical Device Classification Catalog Issued by the CFDA
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Clinical , Regulatory
August 30, 2017
The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
By: Richard Kotz, Senior Product Development Strategist
Medical Device Testing , NAMSA Press Release
August 28, 2017
NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Asian Market , Regulatory
August 16, 2017
Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , Regulatory
July 26, 2017
EU MDR Poses Significant Changes for Importers and Distributors
By: Stephan Buttron
Asian Market , NAMSA Press Release
July 17, 2017
NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Asian Market , Quality
July 11, 2017
Focus on Japan Series: Part IV – Streamlining the Quality Management System Approval Process
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Asian Market , Regulatory
June 26, 2017
China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
Regulatory
June 15, 2017
Risk: An Emerging Driver for New Regulatory Requirements
By: Stephan Buttron
NAMSA Press Release
June 6, 2017
NAMSA Celebrates 50 Years of Scientific Innovation in the Medtech Industry
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA