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 …
Recent Articles
UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
On the 24 January 2019, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published contingency legislation which provides regulatory guidance for medicines, medical devices and clinical trials in the …
EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
The EU Commission’s website dedicated to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning has recently been updated, and now includes a new and dedicated page for …
Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. The compliance deadline of May …
EU Commission & MDCG Release New MDR & IVDR Guidance Documents
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 …
Social Media
Friday, February 22nd, 2019 at 8:00am
Are you an early-stage #medicaldevice firm? There is still time to register for NAMSA's complimentary Start-Up Summit on February 28 to learn proven strategies for efficient, cost-effective product development. https://t.co/zXmrNqlwRN #reimbursement #MRO #CRO #medtech https://t.co/9OXgWYUMho
Are you an early-stage #medicaldevice firm? There is still time to register for NAMSA's complimentary Start-Up Summit on February 28 to learn proven strategies for efficient, cost-effective product development. https://t.co/zXmrNqlwRN #reimbursement #MRO #CRO #medtech https://t.co/9OXgWYUMho
Friday, February 22nd, 2019 at 4:00am
Join NAMSA at the 11th Annual EU Medical Device Clinical Research Conference in Berlin, Germany. Our #medicaldevice development experts will be available throughout the conference for complimentary consultations. Learn more: https://t.co/mUZHFpWRid #clinical #medtech #regulatory https://t.co/P24rbbMnCN
Join NAMSA at the 11th Annual EU Medical Device Clinical Research Conference in Berlin, Germany. Our #medicaldevice development experts will be available throughout the conference for complimentary consultations. Learn more: https://t.co/mUZHFpWRid #clinical #medtech #regulatory https://t.co/P24rbbMnCN
Thursday, February 21st, 2019 at 12:19pm
Join NAMSA on March 20 for our latest webinar, “Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary,” presented by Linda Mummah-Schendel (Principal Quality Consultant, NAMSA). https://t.co/YdZdlY3ET4 #quality #medicaldevice #medtech #MRO #CRO https://t.co/rUcvqX0icZ
Join NAMSA on March 20 for our latest webinar, “Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary,” presented by Linda Mummah-Schendel (Principal Quality Consultant, NAMSA). https://t.co/YdZdlY3ET4 #quality #medicaldevice #medtech #MRO #CRO https://t.co/rUcvqX0icZ
Wednesday, February 20th, 2019 at 11:04pm
NAMSA invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 March. Stop by booth #813 for a complimentary consultation or schedule an appointment with us ahead of time. Learn more: https://t.co/FZ2oKHndKg #medicaldevice #medtech #CRO #MRO #biologicalsafety https://t.co/2fQwMTh6eC
NAMSA invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 March. Stop by booth #813 for a complimentary consultation or schedule an appointment with us ahead of time. Learn more: https://t.co/FZ2oKHndKg #medicaldevice #medtech #CRO #MRO #biologicalsafety https://t.co/2fQwMTh6eC
Wednesday, February 20th, 2019 at 8:05am
Join NAMSA on Feb. 28 in Minneapolis, MN for our complimentary Start-Up Summit, a unique event that will provide early-stage #medicaldevice organizations with best practices and guidance for product development, #FDA trends and reimbursement. https://t.co/sJuQDFDj2E #medtech #CRO https://t.co/Q9Ahf1LMNG
Join NAMSA on Feb. 28 in Minneapolis, MN for our complimentary Start-Up Summit, a unique event that will provide early-stage #medicaldevice organizations with best practices and guidance for product development, #FDA trends and reimbursement. https://t.co/sJuQDFDj2E #medtech #CRO https://t.co/Q9Ahf1LMNG
Wednesday, February 20th, 2019 at 5:03am
With EU Medical Device Regulation (MDR) compliance timeframes quickly approaching, the pressure of implementing transition plans for #medicaldevice manufactures is increasing. Join NAMSA on 28 March 2019 for our #MDR Summit in Aachen, Germany. https://t.co/o8zY6k3xzm #regulatory https://t.co/HTgRhG6T4D
With EU Medical Device Regulation (MDR) compliance timeframes quickly approaching, the pressure of implementing transition plans for #medicaldevice manufactures is increasing. Join NAMSA on 28 March 2019 for our #MDR Summit in Aachen, Germany. https://t.co/o8zY6k3xzm #regulatory https://t.co/HTgRhG6T4D
Trending Articles
The Need for an Authorized Representative for Clinical Trials in the EU
Our previous email and blog post discussed the importance of preclinical studies to clinical trials. A vital step in the “benchtop to bedside” process model is the move from research …
EU MDR Poses Significant Changes for Importers and Distributors
The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in …
Differences and Similarities in Investigator Selection Between the US and EU
The regulatory bodies in the EU and US have set standards that are necessary for a clinical investigator to be compliant with when performing clinical studies. It is important establish …