The first half of October experienced a (small) flurry of activity from key stakeholders implementing the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In …
Recent Articles
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within …
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance …
EU MDR and IVDR Compliance Planning Resources
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical …
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 …
Social Media
Thursday, October 18th, 2018 at 12:02pm
As #IVD markets and regulations change, it’s imperative to stay up-to-date on clinical trial components required to facilitate efficient, cost-effective market approvals. Join us for our upcoming webinar to learn more: https://t.co/lYHlTbJ5MK #CRO #MRO #medtech #EU #IVDR https://t.co/zGYdU8v9tw
As #IVD markets and regulations change, it’s imperative to stay up-to-date on clinical trial components required to facilitate efficient, cost-effective market approvals. Join us for our upcoming webinar to learn more: https://t.co/lYHlTbJ5MK #CRO #MRO #medtech #EU #IVDR https://t.co/zGYdU8v9tw
Wednesday, October 17th, 2018 at 2:34pm
The #EU Commission and #MDCG just released #MDR and #IVDR guidance documents, including templates for Field Safety Notices (FSN) under the existing EU Directives. Access our @NAMSA_MRO's #blog post to learn more: https://t.co/y6HoawOMVX #medicaldevice #medtech #MRO #CRO https://t.co/YHoYOiYIiG
The #EU Commission and #MDCG just released #MDR and #IVDR guidance documents, including templates for Field Safety Notices (FSN) under the existing EU Directives. Access our @NAMSA_MRO's #blog post to learn more: https://t.co/y6HoawOMVX #medicaldevice #medtech #MRO #CRO https://t.co/YHoYOiYIiG
Wednesday, October 10th, 2018 at 9:57am
@DeviceTalks? Stop by to learn how NAGLREITER and NAMSA are partnering to provide device manufacturers time and cost savings throughout the development continuum: Booth #615! https://t.co/LaAhzgs1qD https://t.co/rlh7GVHD0g
@DeviceTalks? Stop by to learn how NAGLREITER and NAMSA are partnering to provide device manufacturers time and cost savings throughout the development continuum: Booth #615! https://t.co/LaAhzgs1qD https://t.co/rlh7GVHD0g
Wednesday, October 10th, 2018 at 8:06am
Learn direct from the experts! Join NAMSA for the MD&M session: "Employing Evolutionary Design while Satisfying the Requirements for an FDA-Compliant Process,” on Oct. 31 from 8:30-10:00 AM CT. More info here: https://t.co/dlwKJwW1P7 #medtech #medicadevice #FDA https://t.co/N8fyk6hG6z
Learn direct from the experts! Join NAMSA for the MD&M session: "Employing Evolutionary Design while Satisfying the Requirements for an FDA-Compliant Process,” on Oct. 31 from 8:30-10:00 AM CT. More info here: https://t.co/dlwKJwW1P7 #medtech #medicadevice #FDA https://t.co/N8fyk6hG6z
Monday, October 8th, 2018 at 8:23am
Join NAMSA this week @DeviceTalks! Stop by Booth #615 to learn how our proven regulatory consulting and clinical research services provide clients time and cost efficiencies throughout the medical device development continuum. #CRO #MRO #medtech
https://t.co/rSpaHum9Vz https://t.co/pjWPXVF7zB
Join NAMSA this week @DeviceTalks! Stop by Booth #615 to learn how our proven regulatory consulting and clinical research services provide clients time and cost efficiencies throughout the medical device development continuum. #CRO #MRO #medtech
https://t.co/rSpaHum9Vz https://t.co/pjWPXVF7zB
Friday, October 5th, 2018 at 11:24am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics. Join us for our European biological safety programs - these sessions will sell out quickly – register today! https://t.co/cDeCiiHtd6 https://t.co/rsiN0iuHi8
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics. Join us for our European biological safety programs - these sessions will sell out quickly – register today! https://t.co/cDeCiiHtd6 https://t.co/rsiN0iuHi8
Trending Articles
Engaging the Best Notified Body to Certify Your Device in the EU
Before a medical device can be marketed in the European Union (EU), it must undergo CE Marking certification and the manufacturer must affix a CE Mark on the device. In …
Important Considerations for Labelling of Medical Devices Under the New EU MDR
The new European Medical Device Regulation (MDR) gives great importance to the information supplied by a manufacturer to the end user to assist with the safe and proper use of …
FDA Warning Letters for Non-US Manufacturers
The US Food and Drug Administration (FDA) has recently released information on 14 warning letters to non-US device manufactures. These letters were delivered from the Center for Devices and Radiological …