The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) 2017/745 has introduced a number of Quality Management System (QMS) requirements for In Vitro Diagnostic (IVD) manufacturers. Most of the self-declared …
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MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
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 …
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 …
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Tuesday, January 21st, 2020 at 1:45pm
From defining and prioritizing reports required for the EU MDR/IVDR to manuscript submissions and literature summaries, NAMSA's team of 45+ global medical writing experts are here to help support your development and commercialization efforts. Lean more: https://t.co/Lnf40fDIBw https://t.co/0u5ugRaEl7
From defining and prioritizing reports required for the EU MDR/IVDR to manuscript submissions and literature summaries, NAMSA's team of 45+ global medical writing experts are here to help support your development and commercialization efforts. Lean more: https://t.co/Lnf40fDIBw https://t.co/0u5ugRaEl7
Tuesday, January 21st, 2020 at 10:53am
Join NAMSA tomorrow (Jan. 22) for our latest webinar to gain a deeper understanding about how to determine if a device qualifies as SaMD, the challenges and opportunities of SaMD and more. https://t.co/oyM2Dnc4Rk #medtech #medicaldevice #samd #CRO #MRO https://t.co/fSvjLZs1o0
Join NAMSA tomorrow (Jan. 22) for our latest webinar to gain a deeper understanding about how to determine if a device qualifies as SaMD, the challenges and opportunities of SaMD and more. https://t.co/oyM2Dnc4Rk #medtech #medicaldevice #samd #CRO #MRO https://t.co/fSvjLZs1o0
Monday, January 20th, 2020 at 1:14pm
Join NAMSA for its upcoming webinar as we walk though strategies for effective utilization of ISO 10993-18:2020 to demonstrate proper safety evaluation and more. Register today: https://t.co/2Wr1WdAb9z #iso #biocompatibility #characterization #medtech #medicaldeivce #evaluation https://t.co/GupxtyFt3y
Join NAMSA for its upcoming webinar as we walk though strategies for effective utilization of ISO 10993-18:2020 to demonstrate proper safety evaluation and more. Register today: https://t.co/2Wr1WdAb9z #iso #biocompatibility #characterization #medtech #medicaldeivce #evaluation https://t.co/GupxtyFt3y
Friday, January 17th, 2020 at 8:06am
Join NAMSA on 25 Feb. for a workshop dedicated to best practices for meeting regulatory requirements for chemical characterization and characterization of materials and devices. Register today: https://t.co/PtinhFLMvr #FDA #MDR #EU #characterization #CRO #ISO https://t.co/KKg9dygSQy
Join NAMSA on 25 Feb. for a workshop dedicated to best practices for meeting regulatory requirements for chemical characterization and characterization of materials and devices. Register today: https://t.co/PtinhFLMvr #FDA #MDR #EU #characterization #CRO #ISO https://t.co/KKg9dygSQy
Wednesday, January 15th, 2020 at 8:01am
Join NAMSA on Feb. 19 for our latest webinar to gain a better understanding of IVDR QMS requirements, ISO 14971 and other critical components to achieve IVDR conformity.
https://t.co/3AdrhoY1Cp #EU #IVDR #QMS #ISO #CRO #regulatory https://t.co/Pw9xT6ajV9
Join NAMSA on Feb. 19 for our latest webinar to gain a better understanding of IVDR QMS requirements, ISO 14971 and other critical components to achieve IVDR conformity.
https://t.co/3AdrhoY1Cp #EU #IVDR #QMS #ISO #CRO #regulatory https://t.co/Pw9xT6ajV9
Tuesday, January 14th, 2020 at 10:48am
Join NAMSA and Baker McKenzie during the J.P. Morgan Healthcare Conference today for an interactive panel discussion designed to help attendees gain a strong understanding of #FDA and EMA issues, challenges faced by start-ups in the global market and more. https://t.co/3iiAtCYSBn https://t.co/s2rmeg0joS
Join NAMSA and Baker McKenzie during the J.P. Morgan Healthcare Conference today for an interactive panel discussion designed to help attendees gain a strong understanding of #FDA and EMA issues, challenges faced by start-ups in the global market and more. https://t.co/3iiAtCYSBn https://t.co/s2rmeg0joS
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 …