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 …
Recent Articles
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 …
Draft Corrigenda for EU MDR and IVDR Released
The EU Commission has released draft documents correcting aspects of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These drafts are currently under review by …
EMA Issues Q&A Regarding Impact of MDR, Article 117
Often overlooked, Article II7 of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) lurks within Chapter X of the Final Provisions. However, this article is of high impact to …
EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,” that described the consequences …
Social Media
Thursday, October 10th, 2019 at 10:03am
Access our latest White Paper to gain an in-depth understanding of Human Factors regulatory guidance and practical steps on how to tackle this key area of #design and development to ensure patient safety. https://t.co/33ls1zXpWN #humanfactors #medicaldevice #medtech #usability https://t.co/d0k61jvrer
Access our latest White Paper to gain an in-depth understanding of Human Factors regulatory guidance and practical steps on how to tackle this key area of #design and development to ensure patient safety. https://t.co/33ls1zXpWN #humanfactors #medicaldevice #medtech #usability https://t.co/d0k61jvrer
Wednesday, October 9th, 2019 at 2:12pm
NAMSA’s “BiocompCHATibility” Podcast, a first-of-its-kind series dedicated to all things medical device #biocompatibility, has released a new episode. Tune in today! https://t.co/CunXVnAMqd #medtech #medicaldevice #CRO https://t.co/EvGfWlXgSP
NAMSA’s “BiocompCHATibility” Podcast, a first-of-its-kind series dedicated to all things medical device #biocompatibility, has released a new episode. Tune in today! https://t.co/CunXVnAMqd #medtech #medicaldevice #CRO https://t.co/EvGfWlXgSP
Tuesday, October 8th, 2019 at 6:03am
Press Release: NAMSA expands European medical device testing solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation—Obernburg, Germany Analytical Services Laboratory. Read more: https://t.co/yHsUJofcwQ #EU #medicaldevice #medtech #dakks https://t.co/DCLVSPvIeh
Press Release: NAMSA expands European medical device testing solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation—Obernburg, Germany Analytical Services Laboratory. Read more: https://t.co/yHsUJofcwQ #EU #medicaldevice #medtech #dakks https://t.co/DCLVSPvIeh
Thursday, October 3rd, 2019 at 7:56am
On 26 September, the #MDCG issued guidance on #SSCP requirements to assist in meeting the MDR objectives of increased patient safety and benefit. How will this affect your #MDR strategy and operations? https://t.co/fjU5lNr471 #EU #MDD https://t.co/7VvAncHZmz
On 26 September, the #MDCG issued guidance on #SSCP requirements to assist in meeting the MDR objectives of increased patient safety and benefit. How will this affect your #MDR strategy and operations? https://t.co/fjU5lNr471 #EU #MDD https://t.co/7VvAncHZmz
Monday, September 30th, 2019 at 6:04am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available): https://t.co/mojEgCEo5e #medtech #characterization #biologicalsafety #EU #MDR https://t.co/AyXIHmUw70
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available): https://t.co/mojEgCEo5e #medtech #characterization #biologicalsafety #EU #MDR https://t.co/AyXIHmUw70
Friday, September 27th, 2019 at 9:08am
Check out NAMSA's “BiocompCHATibility” Podcast, a first-of-its-kind series dedicated to all things medical device #biocompatibility. The first three episodes are now available at no cost to listeners at: https://t.co/f3ew3ekVE7 https://t.co/ZdmretwdsN
Check out NAMSA's “BiocompCHATibility” Podcast, a first-of-its-kind series dedicated to all things medical device #biocompatibility. The first three episodes are now available at no cost to listeners at: https://t.co/f3ew3ekVE7 https://t.co/ZdmretwdsN
Trending Articles
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 …
EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
On 10 January 2018, the EU Commission issued the document, “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” While this notice …
MEDDEV 2.7.1 Revision 4 – Stricter Requirements for Clinical Evaluation Reports
After some delays, Revision 4 of Clinical Evaluation MEDDEV guidance document 2.7.1 was released by the European Commission on July 1, 2016. Although the new revision is slightly larger in …