As EU medical device manufacturers and sponsors scramble to meet Medical Device Regulation (MDR) conformity in just six months, a second draft corrigenda was published on 25 November 2019 that …
Recent Articles
Key Requirements of Post-Market Surveillance under IVDR
Important elements revolve around maintaining quality, performance and safety throughout the product lifecycle. As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in …
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
The European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC), introduces risk–based classification for IVD devices, in addition to new and …
NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany
Tuesday, October 8, 2019–FRANKFURT, Germany–(BUSINESS WIRE)–NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, and reimbursement and regulatory consulting services, is …
MDCG ISSUES Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
On 26 September 2019, the Medical Device Coordination Group (MDCG) released final guidance regarding Summary of Safety and Clinical Performance (SSCP), which is intended to serve as a guide for …
Social Media
Friday, December 13th, 2019 at 5:34am
The EU’s #IVDR sets forth multiple new requirements for #EU #IVD Sponsors. Access NAMSA’s “IVDR Readiness Guide” to gain a deeper understanding of key conformity steps, and to understand your current levels of IVDR readiness. https://t.co/DvhjUNH1PV #medtech #diagnostics https://t.co/wjwQdZvhLP
The EU’s #IVDR sets forth multiple new requirements for #EU #IVD Sponsors. Access NAMSA’s “IVDR Readiness Guide” to gain a deeper understanding of key conformity steps, and to understand your current levels of IVDR readiness. https://t.co/DvhjUNH1PV #medtech #diagnostics https://t.co/wjwQdZvhLP
Thursday, December 12th, 2019 at 6:01am
November 26 marked the official 6-month countdown to mandatory #MDR compliance (May 26, 2020). Contact NAMSA to learn more: https://t.co/nAXUmXdAmb or visit our complimentary MDR planning resources page at: https://t.co/fzNmnBd4w4 #EU #MDD #medtech #medicaldevice #eucommission https://t.co/ab2sFdJfeD
November 26 marked the official 6-month countdown to mandatory #MDR compliance (May 26, 2020). Contact NAMSA to learn more: https://t.co/nAXUmXdAmb or visit our complimentary MDR planning resources page at: https://t.co/fzNmnBd4w4 #EU #MDD #medtech #medicaldevice #eucommission https://t.co/ab2sFdJfeD
Monday, December 9th, 2019 at 7:32am
Join NAMSA for its highly sought-after training series in San Diego on Jan. 27-30. Learn about the practical use of #biocompatibility planning & implementation, risk assessments and more. Early-bird registration ends Dec. 31, 2019. https://t.co/PS4YifFFAv #CRO #MRO #FDA #ISO https://t.co/VZ2w2QjVCH
Join NAMSA for its highly sought-after training series in San Diego on Jan. 27-30. Learn about the practical use of #biocompatibility planning & implementation, risk assessments and more. Early-bird registration ends Dec. 31, 2019. https://t.co/PS4YifFFAv #CRO #MRO #FDA #ISO https://t.co/VZ2w2QjVCH
Friday, December 6th, 2019 at 6:31am
Have you checked out NAMSA's “Biocompatibility Strategy Navigator” yet? Access this first-of-its-kind online resource to help your organization simplify the process of identifying #biological endpoint assessments for intended global #regulatory pathways: https://t.co/j1wtuR9fCn https://t.co/L9VxrbYRwY
Have you checked out NAMSA's “Biocompatibility Strategy Navigator” yet? Access this first-of-its-kind online resource to help your organization simplify the process of identifying #biological endpoint assessments for intended global #regulatory pathways: https://t.co/j1wtuR9fCn https://t.co/L9VxrbYRwY
Thursday, December 5th, 2019 at 8:17am
Want to expand your knowledge of the medical device industry but don’t have the time to travel to a conference? Check out NAMSA’s e-Learning courses today! https://t.co/bEY5IHLCOC #medicaldevice #medtech #MRO #CRO https://t.co/TML45fzAwO
Want to expand your knowledge of the medical device industry but don’t have the time to travel to a conference? Check out NAMSA’s e-Learning courses today! https://t.co/bEY5IHLCOC #medicaldevice #medtech #MRO #CRO https://t.co/TML45fzAwO
Wednesday, December 4th, 2019 at 9:05am
On September 20, 2019, #FDA issued a new draft guidance with the intent to reduce the regulatory burden on the #medicaldevice industry through consensus of efficiency requirements. Learn more: https://t.co/zsRUTv0cG8 #CRO #MRO #medtech #premarketapproval #CDRH #CBER https://t.co/0sy163tzrb
On September 20, 2019, #FDA issued a new draft guidance with the intent to reduce the regulatory burden on the #medicaldevice industry through consensus of efficiency requirements. Learn more: https://t.co/zsRUTv0cG8 #CRO #MRO #medtech #premarketapproval #CDRH #CBER https://t.co/0sy163tzrb
Trending Articles
EU Parliament Votes to Institute the New IVDR and MDR Regulations; Transition Period Expected to Begin on June 1, 2017
The New EU Medical Devices Regulation (MDR) and In vitro Diagnostics Regulation (IVDR) were approved by the EU Parliament on April 5, 2017. The final regulations, expected to be published …
Updated German Legislation for Medical Devices
Following the EU regulation updates, the German legislator amended regulations relating to medical products to better align with the changing market. Existing databases were also updated so authorities and consumers …
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
Introduction Increasingly, the world is engaged in conversations surrounding mobile and digital health applications. These types of platforms – broadly defined – encompass everything from pedometers, fitness apps, exercise diaries …