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NAMSA, the world’s only 100% medical device-focused CRO providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition will enhance NAMSA’s already robust cardiovascular-focused regulatory consulting and clinical research solutions, while expanding EDC capabilities, core lab imaging, safety and physician consulting services. Partnering together, NAMSA looks forward to further strengthening its rich history of assisting Sponsors to proactively tackle development challenges head-on, achieve commercialization success and positively impact patient lives. Access our full Press Release now: www.namsa.com/namsa_acquires_clinical_cro_syntactx @ArchiMed @Syntactx #acquisition #clinicalresearch #medicaldevices #medtech
Exciting news for the next chapter in NAMSA's history!
During uncertain times like the one we are in today, it is such a relief to know the company you work for takes such great care of their Associates, Clients and the business. Our leadership team is frankly, is the best and the Associates working at NAMSA are not just full of knowledge and experience, they have big hearts too! Together and with the help of family and friends of NAMSA, we were able to make fabric masks for all of our Associates! This is just one of the many reasons why NAMSA is a great place to work! Our sincere gratitude and a big thank you to all of you for making this happen!
On 7 April, the European Council provided feedback regarding the European Commission’s proposal to delay the date of application of certain EU MDR provisions by one year (26 May 2021) in light of the COVID-19 pandemic. Critical Update: The proposed delay to the new date of application would apply to Article 120(3), allowing manufacturers to: 1) extend MDD Certificates; 2) make significant changes and changes to intended purpose; and 3) possess adequate time to prepare QMS to meet stricter PMS, market surveillance, vigilance and arrangement of Economic Operators requirements. What does this mean for your EU medical device operations? Our regulatory experts break it down: post:https://www.namsa.com/european-market/ec-mandate-eu-parliament-mdr-delay-section120/ #MDR #EU #MDD #medtech #medicaldevices @NAMSA_MRO
@NAMSA_MRO #Press Release: NAMSA recognized as a leading medical device CRO for second consecutive year by Life Science Leader; honored as a top performer in the categories of Data Quality and Access, Meeting Project Timelines, Operational Excellence, and Responsiveness http://glassdoor.com/slink.htm?key=vQWIF #MRO #CRO #clinicalresearch #IVD #clinicaltrials #medtech
NAMSA invites you to access our recent video testimonial with French biosurgical firm, Biom’Up. Interviewed is Etienne Binant, CEO of Biom’Up, and includes a discussion on NAMSA’s MRO® Approach – a unique strategic process which provides guidance and support throughout the full device development continuum. Learn how Biom’Up achieved $17M in cost savings and 23 months in accelerated timelines for their FDA PMA/IDE submission through a NAMSA partnership. http://glassdoor.com/slink.htm?key=vQjB5 @NAMSA_MRO #medtech #medicaldevice #clinicalresearch #FDA #EU
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NAMSA Launches New Analytical Services Laboratory in Germany, Announces Grand Opening As the creator of the medical device testing industry and marketplace leader for over 50 years, NAMSA is pleased to announce the launch of its Analytical Services Laboratory in Obernburg, Germany. This new state-of-the-art lab will now offer EU manufacturers a centrally-located, high-quality partner for ISO 10993-18 testing. To celebrate this milestone, NAMSA will hold a Grand Opening on 6 March (14:00 – 20:00 CET) which will feature lab tours, consultations, scientific sessions, government official and keynote addresses, and a networking reception. If you are interested in attending, please click the link below to learn more. We hope to see you there! http://glassdoor.com/slink.htm?key=vQUKL #medtech #ISO #medicaldevice #testing #germany @NAMSA_MRO
