The most recently revised “Medical Device Registration” and “in vitro diagnostic reagents Registration” (China Food and Drug Administration Order No. 4 an No. 5) came into effect October 1, 2014. To address …
Recent Articles
NAMSA Expands Service Offering Expertise Into South America
Northwood, OH – October 2015 – NAMSA, the world’s leading medical research organization is pleased to announce the addition of Blanchard & Associates as NAMSA’s local agent in South America. …
Traceability in Device Design, Development, and Distribution
The path through medical device design, testing, application, and maintenance needs to be traceable. Traceability analyses aid in understanding device design and whether requirements are being met. According to FDA, …
Medical Device Development: Design Validation and Preclinical, Part 2
Packaging and sterilization. Aside from the safety and efficacy of the device itself, the packaging and final processing must also be considered. The packaging material selection should be based on …
Medical Device Development: Design Validation and Preclinical, Part 1
The preclinical stage of device development is a vital one for medical device manufacturers. This is the stage in which the design of the product is set, including functionality and …
Social Media
Friday, March 27th, 2020 at 10:25am
NAMSA continues to closely monitor the COVID-19 health situation currently impacting our global community. To learn how NAMSA continues to support global clients during this pandemic, please visit: https://t.co/QIZLODvXoU #covid19 #criticalcare #essentialbusiness https://t.co/lA5lZxlvgW
NAMSA continues to closely monitor the COVID-19 health situation currently impacting our global community. To learn how NAMSA continues to support global clients during this pandemic, please visit: https://t.co/QIZLODvXoU #covid19 #criticalcare #essentialbusiness https://t.co/lA5lZxlvgW
Friday, March 27th, 2020 at 9:09am
With the current global concerns around COVID-19, expanding your knowledge of medical device development best practices and strategies can be challenging. NAMSA offers e-Learning courses! Sign up today: https://t.co/i1voOskEPg #medicaldevices #medtech #MRO #CRO https://t.co/KH5shZiurP
With the current global concerns around COVID-19, expanding your knowledge of medical device development best practices and strategies can be challenging. NAMSA offers e-Learning courses! Sign up today: https://t.co/i1voOskEPg #medicaldevices #medtech #MRO #CRO https://t.co/KH5shZiurP
Thursday, March 26th, 2020 at 11:14am
The COVID-19 pandemic is threatening the validity of many #clinicalresearch programs currently underway. Join NAMSA on April 1 for our latest webinar, “The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity.” https://t.co/8hyXzCmZCy #covid #coronavirus https://t.co/5N9zOzLlya
The COVID-19 pandemic is threatening the validity of many #clinicalresearch programs currently underway. Join NAMSA on April 1 for our latest webinar, “The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity.” https://t.co/8hyXzCmZCy #covid #coronavirus https://t.co/5N9zOzLlya
Thursday, March 26th, 2020 at 8:48am
Join NAMSA for our webinar, “Do’s and Don’ts for Early-Stage IVD Product Development and Risk Mitigation,” on April 22 at 11 AM Eastern and discover how to navigate a variety of scenarios to gauge time and cost-to-market. Register today! https://t.co/Fq97Ctdv8r #IVD #CRO #FDA https://t.co/YpCCA9lS59
Join NAMSA for our webinar, “Do’s and Don’ts for Early-Stage IVD Product Development and Risk Mitigation,” on April 22 at 11 AM Eastern and discover how to navigate a variety of scenarios to gauge time and cost-to-market. Register today! https://t.co/Fq97Ctdv8r #IVD #CRO #FDA https://t.co/YpCCA9lS59
Wednesday, March 25th, 2020 at 9:53am
Join our hosts as they sit down with Stephanie Taylor, Staff Scientist - Toxicology and Biocompatibility at DePuy Synthes, to discuss reprocessing of reusable devices and the challenges of #biologicalevaluation. https://t.co/87Md3dGPYT #medicaldevices #CRO #medtech #FDA https://t.co/NC3133w6lj
Join our hosts as they sit down with Stephanie Taylor, Staff Scientist - Toxicology and Biocompatibility at DePuy Synthes, to discuss reprocessing of reusable devices and the challenges of #biologicalevaluation. https://t.co/87Md3dGPYT #medicaldevices #CRO #medtech #FDA https://t.co/NC3133w6lj
Tuesday, March 24th, 2020 at 7:14am
Join NAMSA on April 8 for our webinar, “Optimizing Electronic Data Capture (EDC) System for IVD Clinical Trials,” to learn about key factors to consider while selecting an EDC platform and more! https://t.co/VoUzv7279F #CRO #IVD #EDC #clinicalresearch #clinicaltrials https://t.co/G015jXc9HW
Join NAMSA on April 8 for our webinar, “Optimizing Electronic Data Capture (EDC) System for IVD Clinical Trials,” to learn about key factors to consider while selecting an EDC platform and more! https://t.co/VoUzv7279F #CRO #IVD #EDC #clinicalresearch #clinicaltrials https://t.co/G015jXc9HW
Trending Articles
China Acceptance of Foreign Biocompatibility Reports
The most recently revised “Medical Device Registration” and “in vitro diagnostic reagents Registration” (China Food and Drug Administration Order No. 4 an No. 5) came into effect October 1, 2014. To address …
New Developments in FDA Biocompatibility Requirements for Personal Lubricants
Personal lubricants are a lucrative portion of the medical device market in the US and elsewhere. In the past, the Food and Drug Administration (FDA) has considered them to be …
Moving From In Vitro to In Vivo: What Happens Next?
Preclinical testing of an investigational medical device is a necessary step in obtaining market approval from regulatory agencies. The purpose of preclinical testing is to establish the safety of a …