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

European Market , IVD
June 23, 2022
MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices
Christèle East, PhD
By: Christèle East, PhD
IVD , Medical Writing
June 16, 2022
MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
By: Lucile Ryckebusch
IVD
June 1, 2022
MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity
By: Alex Laan
Clinical , FDA , Regulatory
May 16, 2022
Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry
Kirk Honour
By: Kirk Honour
European Market , Regulatory
May 9, 2022
New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR
Jane Arnold-Round
By: Jane Arnold-Round
Reimbursement
May 2, 2022
The Repeal of MCIT: 3 Key Takeaways for Medical Device Manufacturers
Rebecca Lanquist
By: Rebecca Lanquist
Regulatory
April 13, 2022
FDA Announces Optional Pathway for Clearance of Surgical Sutures
By: Kelly Kucharczyk, RAC
Regulatory
April 12, 2022
FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
By: Monica R. Montanez
NAMSA Press Release , Preclinical
March 30, 2022
NAMSA ACQUIRES EUROPEAN-BASED MEDANEX CLINIC TO EXPAND EARLY-STAGE PRECLINICAL RESEARCH CAPABILITIES
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
NAMSA Press Release
March 21, 2022
NAMSA ACQUIRES CONTRACT RESEARCH ORGANIZATION, ÅKRN
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Preclinical
March 16, 2022
Incorporating CT Imaging into Preclinical Studies
Monica Tantalean
By: Monica Tantalean
FDA , Quality
March 7, 2022
Industry Update: Proposed FDA Ruling of Changes to 21 CFR part 820-QSR
Principal Quality Systems Consultant
By: Lisa Schwartz
European Market , Regulatory
March 1, 2022
New MDCG 2022-4 Guidance Released
Sr. Regulatory Consultant
By: Thomas Miramond
FDA , Quality , Regulatory
February 28, 2022
Industry Update: U.S. FDA Quality Management System Regulation
Principal Quality Systems Consultant
By: Lisa Schwartz
FDA , Medical Device Testing , Toxicology
February 23, 2022
ACS Releases Review of Chemical Characterization Practices for Medical Devices on Behalf of FDA
By: Nicholas Keyes
FDA , Regulatory
January 31, 2022
FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”
By: Monica R. Montanez
Histology , Medical Device Testing
January 27, 2022
Considerations for Medical Device Histology Tissue Preparation
By: Julie Blanch, HT (ASCP) QIHC
European Market , Regulatory
January 20, 2022
New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR
David Mandley
By: David Mandley, PhD
European Market , Regulatory
January 13, 2022
European Commission Releases Further Harmonised Standards under EU MDR
David Mandley
By: David Mandley, PhD
FDA , IVD , Regulatory
January 11, 2022
FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions
By: Kelly Kucharczyk, RAC
FDA , Regulatory
December 13, 2021
FDA Releases 3D Printing at the Point of Care Discussion Paper
By: Kelly Kucharczyk, RAC
FDA , Regulatory
December 3, 2021
FDA Announces Release of “Playbook for Threat Modeling Medical Devices”
By: Monica R. Montanez
NAMSA Press Release
November 11, 2021
NAMSA Expands Minneapolis Preclinical Laboratory to Meet Industry Demand for Medtech Research and Development Solutions
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
FDA , Regulatory
November 3, 2021
FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions
By: Monica R. Montanez
Clinical
November 3, 2021
Interventional Oncology: Fast Forward to the Future
Dr. Jean-Francois Geschwind
By: Dr. Jean-Francois H. Geschwind
European Market , Regulatory
October 27, 2021
MDCG Publishes New Legacy Device Guidance 2021-25
Paul Risborough
By: Paul Risborough
European Market , Regulatory
October 11, 2021
MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24
By: Kevin Butcher
Clinical , NAMSA Press Release
August 2, 2021
NAMSA ACQUIRES LEADING CLINICAL RESEARCH ORGANIZATION CLINLOGIX TO ENHANCE THERAPEUTIC EXPERTISE AND GLOBAL FOOTPRINT
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
FDA , Medical Device Testing , NAMSA Press Release
July 28, 2021
NAMSA First to Receive FDA ASCA Accreditation for Medical Device Biocompatibility Testing
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
FDA , Regulatory
June 7, 2021
FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers
Kirk Honour
By: Kirk Honour
Clinical & Consulting , European Market , Regulatory
May 25, 2021
May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers
By: Adrian Keene
Clinical , FDA , Medical Device Testing , Regulatory
May 11, 2021
Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Asian Market , IVD , Regulatory
May 10, 2021
China State Council Releases Order 739, Creating New Market Access Opportunities for Global Medical Device and IVD Manufacturers
By: Lillian Li
FDA , Regulatory
April 28, 2021
FDA Qualifies New Cybersecurity Medical Device Development Tool
Principal Quality Systems Consultant at NAMSA Clinical & Consulting
By: Lezlie Hynes
European Market , IVD , Regulatory
April 21, 2021
MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR
Jane Arnold-Round
By: Jane Arnold-Round
FDA , Medical Device Testing
March 18, 2021
FDA CDRH Announces New Resource for Medical Device Biocompatibility Assessments 
Nicole Bronson
By: Nicole Bronson, BIS
NAMSA Press Release
March 11, 2021
NAMSA Begins Next Chapter of Growth under Newly Appointed CEO, Dr. Christophe Berthoux
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
NAMSA Press Release , Preclinical
March 2, 2021
NAMSA Acquires American Preclinical Services
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
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
Angela Mallery
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
Leah Davidson, MA, MBA
By: Leah 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
Archimed Acquires Majority Interest in NAMSA
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Angela Mallery
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
Leah Davidson, MA, MBA
By: Leah 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’
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Richard Kotz
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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
FDA , Regulatory
November 28, 2018
FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program
Richard Kotz
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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Clinical , NAMSA Press Release
October 30, 2018
NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
Leah Davidson, MA, MBA
By: Leah 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?
Richard Kotz
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
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
FDA , Regulatory
January 23, 2018
Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings
Angela Mallery
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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
European Market , NAMSA Press Release
October 30, 2017
NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Clinical , Regulatory
August 30, 2017
The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
Richard Kotz
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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Asian Market , Regulatory
August 16, 2017
Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Asian Market , Quality
July 11, 2017
Focus on Japan Series: Part IV – Streamlining the Quality Management System Approval Process
Leah Davidson, MA, MBA
By: Leah Davidson, MA, MBA
Asian Market , Regulatory
June 26, 2017
China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)
Leah Davidson, MA, MBA
By: Leah 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
Leah Davidson, MA, MBA
By: Leah 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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