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

FDA , Regulatory
October 2, 2023
FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents
Ed Arscott
By: Ed Arscott, BS
Regulatory
September 28, 2023
The Swiss MedTech Landscape
By: Sara Finocchietti, MEng, PhD
FDA , Regulatory
September 21, 2023
FDA Publishes Updated Guidance for Breakthrough Devices Program
Carla Wiese
By: Carla M. Wiese, BS-Mech Eng
FDA , Regulatory
September 18, 2023
FDA Announces Three New Guidances Dedicated to 510(k) Submissions
By: Marcella Martin
Medical Device Testing , Preclinical
September 6, 2023
Mechanical Hemolysis Assay for Blood Contacting Devices
By: Sarah Howard
FDA , Regulatory
August 21, 2023
FDA Revised its Final Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”
By: Marcella Martin
FDA , Regulatory
August 15, 2023
FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices
By: Marcella Martin
FDA
August 2, 2023
FDA Publishes Medical Device User Fees for Fiscal Year 2024
By: Marcella Martin
Medical Device Testing
July 26, 2023
5 Steps for A Successful Medical Device Go-To-Market Strategy
By: Monica Tantalean
Medical Device Testing
July 19, 2023
Medical Device Commercialization Process: Q&A
By: Monica Tantalean
Press Release
July 18, 2023
NAMSA Acquires German-Based CRI to Expand Clinical Research and Geographic Reach Across Europe
Chris Rupp
By: Chris Rupp, MBA
Clinical & Consulting
July 12, 2023
Clinical Trial Cost Analysis with Site Budget Estimates
By: Wendy Schroeder, RN, BSN, CCRC/PM, CRCP
European Market , Regulatory
June 22, 2023
UK Extends Transition Period for Medical Device and IVD Products in New Legislation
Jane Arnold-Round
By: Jane Arnold-Round
Press Release
June 21, 2023
Global MedTech CRO, NAMSA, Announces Strategic Outsourcing Partnership with Terumo Aortic
Chris Rupp
By: Chris Rupp, MBA
European Market , Regulatory
June 1, 2023
Reflecting on the Second Anniversary of the EU Medical Device Regulation
David Mandley
By: David Mandley, PhD
FDA , Medical Device Testing
May 25, 2023
ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience
Sheri Krajewski
By: Sheri Krajewski
Clinical , Clinical & Consulting
May 3, 2023
Your Guide to Biostatistics Outsourcing and Consulting
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
European Market , Regulatory
April 28, 2023
Just Released: Updated Transitional Arrangements for UKCA Process
By: Kevin Butcher
Industry Reposts
April 7, 2023
The New England Journal of Medicine: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
By: Anney Peterson
FDA , Regulatory
April 3, 2023
AI Guidance for Medical Devices | NAMSA
By: Monica R. Montanez
Press Release
March 27, 2023
NAMSA Expands MedTech Portfolio in Market Intelligence and Customer Research Services through its Acquisition of EU-Based SUAZIO
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
European Market , Regulatory
March 8, 2023
UK MHRA Advisory Group Publishes Proposals
By: Kevin Butcher
European Market , IVD , Regulatory
February 22, 2023
European Parliament to Amend MDR/IVDR Transitional Provisions
By: Dr. Rachel Gibbs, PhD, BSc
FDA , IVD , Regulatory
February 8, 2023
U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry
By: Wendy Schroeder, RN, BSN, CCRC/PM, CRCP
FDA , Regulatory
January 18, 2023
Health Canada and FDA eSTAR Pilot
By: Marcella Martin
Reimbursement
January 11, 2023
The Value of Economic Data in Payor Engagement
Rebecca Lanquist
By: Rebecca Lanquist
European Market , Regulatory
December 16, 2022
MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18
By: Kevin Butcher
Clinical & Consulting , European Market , Regulatory
December 6, 2022
EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
Jane Arnold-Round
By: Jane Arnold-Round
Clinical & Consulting , European Market , Regulatory
November 28, 2022
Auditing a QMS According to ISO 13485
By: Ariadna Navarro
Press Release
November 16, 2022
NAMSA Transforms Integrated MedTech Commercialization Solution: The NAMSA APEX Program
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
Microbiology , Press Release
October 4, 2022
NAMSA ACQUIRES UK-BASED PERFECTUS BIOMED GROUP TO ENHANCE CUSTOMIZED MICROBIOLOGICAL SOLUTIONS
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
FDA , Regulatory
September 30, 2022
FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software
By: Monica R. Montanez
FDA , Regulatory
September 28, 2022
Digital Health Software Pre-Certification Update: Final FDA Report Revealed
By: Monica R. Montanez
FDA , IVD , Regulatory
September 22, 2022
Monkeypox: Not all EUAs Are Created Equal
By: Wendy Schroeder, RN, BSN, CCRC/PM, CRCP
European Market , Regulatory
September 13, 2022
First Manual on Borderline and Classification under MDR Published by the European Commission
David Mandley
By: David Mandley, PhD
NAMSA Press Release
September 8, 2022
NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
European Market , Regulatory
September 1, 2022
MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
By: Kevin Butcher
European Market , IVD , Regulatory
August 15, 2022
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
By: Alex Laan
European Market , IVD , Regulatory
July 21, 2022
MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
By: Alex Laan
European Market , IVD , Regulatory
June 30, 2022
The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers
Christèle East, PhD
By: Christèle East, PhD
FDA , Regulatory
June 29, 2022
Navigating the 510(k) EO Sterility Change Master File Program
By: Marcella Martin
European Market , Regulatory
June 28, 2022
New UK MHRA Medical Devices Regulations Published
By: Kevin Butcher
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, PCM
By: Leah Davidson, MA, MBA, PCM
NAMSA Press Release
March 21, 2022
NAMSA ACQUIRES CONTRACT RESEARCH ORGANIZATION, ÅKRN
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
Preclinical
March 16, 2022
Incorporating CT Imaging into Preclinical Studies
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
NAMSA Press Release , Preclinical
March 2, 2021
NAMSA Acquires American Preclinical Services
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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 R. Jameson, PhD
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren R. Jameson, PhD
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
European Market , Quality , Regulatory
July 10, 2019
EU IVDR: Understanding the New QMS Requirements
By: Warren R. Jameson, PhD
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
Clinical , NAMSA Press Release
October 30, 2018
NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
European Market , NAMSA Press Release
October 30, 2017
NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
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 Peterson
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, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
Asian Market , Regulatory
August 16, 2017
Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
Asian Market , Quality
July 11, 2017
Focus on Japan Series: Part IV – Streamlining the Quality Management System Approval Process
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
Asian Market , Regulatory
June 26, 2017
China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)
Leah Davidson, MA, MBA, PCM
By: Leah Davidson, MA, MBA, PCM
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, PCM
By: Leah Davidson, MA, MBA, PCM
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 Peterson
Uncategorized
March 30, 2017
Why Regional Reimbursement Strategies Could Be Right For Medtech
By: Anney Peterson
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 Peterson

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