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

FDA , Regulatory , Reimbursement
February 8, 2021
Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’
Christopher Salmen
By: Christopher Salmen
FDA , Regulatory
January 18, 2021
U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan
By: Monica R. Montanez
FDA , Regulatory
January 12, 2021
U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices
By: Angela Mallery
Clinical , Clinical & Consulting , NAMSA Press Release , Regulatory
January 5, 2021
NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
European Market , IVD , Regulatory
November 24, 2020
New Guidance: Classification of IVD under the IVDR
By: Alex Laan
FDA , Regulatory
November 9, 2020
CDRH COVID-19-Related Workload Impacts Q-Submission Reviews
By: Barbara Atzenhoefer
FDA , Medical Device Testing , Regulatory
October 22, 2020
Industry Update: Accreditation Scheme for Conformity Assessment
By: Melissa Cadaret
FDA , Medical Device Testing , Regulatory , Toxicology
October 19, 2020
FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin
By: Andy Wyen, M.S., DABT
Asian Market , Regulatory
September 23, 2020
Update: PMDA Review Timelines for Medical Device and IVD Products
By: Takashi Tanaka, PhD, RAC
Clinical & Consulting , European Market , IVD , Regulatory
September 9, 2020
UKCA: A Wait and Watch Approach?
By: Richard Bassett
NAMSA Press Release
September 1, 2020
Partnering with Existing Owners and Management, ArchiMed Acquires Majority Interest in NAMSA, the World Leader in Medical Device Testing
Global Manager, Marketing Communications
By: Leah A. Davidson, MA, MBA
FDA , IVD , Regulatory
August 11, 2020
Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications
Uchenna Ifediora, CRA
By: Uchenna Ifediora
Clinical & Consulting , European Market , Regulatory
July 14, 2020
EU Commission Update : Notified Bodies Designated to MDR/IVDR
By: Adrian Keene
Clinical & Consulting , IVD , Regulatory
July 8, 2020
The IVDR Compliance Roadmap: From Start to Finish
By: Jonathan Ripley
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
Uncategorized
May 17, 2017
Focus on Japan Series: Part III – Registering Facilities under Foreign Manufacturer Accreditation (FMA)
User profile photo
By: Leah Davidson
European Market , Regulatory
April 20, 2017
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
By: Anney N. Majewski
Uncategorized
March 30, 2017
Why Regional Reimbursement Strategies Could Be Right For Medtech
By: Anney N. Majewski
Uncategorized
March 8, 2017
Focus on Japan Series: Part II – Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers
User profile photo
By: Leah Davidson
Uncategorized
February 2, 2017
Focus on Japan Series: Part I – Important Factors for Medical Device Development in Japan
User profile photo
By: Leah Davidson
Uncategorized
November 2, 2016
NAMSA Expands Service Offering in China with Opening of Shanghai Laboratory
User profile photo
By: Leah Davidson
Uncategorized
April 11, 2016
FDA Clarifies Policy for Color Additives in Medical Devices
By: Anney N. Majewski

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