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
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
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 …
Introducing NAMSA Connect
Working with NAMSA just got a little easier. NAMSA Connect is a new secure online client portal and data access tool that provides 24/7 availability of test statuses, final reports, …
Advances in Medical Device Materials. Part 1: Polycarbonate Resins
Polycarbonate resins are being used to create promising and versatile new high-performance materials that can be tailored to meet multiple needs: Optical clarity and colorability Durability/impact resistance Ductility for rigorous …