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New FDA CDRH Biocompatibility Assessment Resources NAMSA

WEBThe U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced today that it is now offering an electronic …

Actived: Just Now

URL: https://namsa.com/cdrh-announces-resource-for-medical-device-biocompatibility-assessments/

FDA releases long-awaited final guidance for clinical decision …

WEBOn the heels of the September 26 release of the U.S. Food and Drug Administration’s (FDA), “Digital Health Software Precertification (Pre-Cert) Pilot …

Category: Food Go Health

Medical Device Insurance Reimbursement NAMSA

WEBNAMSA understands government and private payer coverage and payment policies under the current global health economics environment. As such, our team designs strategies …

Category: Health Go Health

digital health software pre-certification update: final FDA

WEBOn September 26, 2022, the U.S. Food and Drug Administration (FDA) released a 31-page final report entitled, “Digital Health Software Precertification (Pre-Cert) Pilot Program: …

Category: Food Go Health

FDA Releases "Predetermined Change Control Plans for Machine …

WEBIn April 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Marketing Submission Recommendations for a Predetermined Change …

Category: Food Go Health

FDA Announces Three New Guidances Dedicated to 510(k) …

WEBOn September 6, 2023, the U.S. Food and Drug Administration (FDA) released a statement about the issuance of the following three new guidances as part of their effort to …

Category: Food Go Health

Human Factors & Usability Design in Medical Devices NAMSA

WEBHuman factors design and usability engineering requirements for medical device design and development are explicitly implemented into current and forthcoming …

Category: Medical Go Health

FDA CDRH Reorganization: Faster Reviews for Medical Device

WEBThe U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is currently undergoing one of its most ambitious reorganizations in decades to …

Category: Food Go Health

FDA Revised its Final Guidance, "Requests for Feedback and …

WEBAn important reminder for medical device sponsors/developers is that on June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the …

Category: Food, Medical Go Health

What Is An Electronic Data Capture (EDC) System in Clinical Trials

WEBAn Electronic Data Capture (EDC) system is software that’s used to electronically collect, manage and store clinical research trial data. This data gets …

Category: Health Go Health

FDA CDRH: New Organizational Structure Effective May 1, 2019

WEBIn the fall of 2018, the U.S. Food & Drug Administration’s (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization …

Category: Food, Medical Go Health

Stricter MDR Rules: CE Marks for Digital Health Tech NAMSA

WEBParagraph (19) reconfirms that the intended medical purpose of digital health apps and wearable body sensors, and not their technological features and advanced capabilities, …

Category: Medical Go Health

Embracing Digital Health Technologies: FDA's New Guidance for …

WEBFDA identified digital health technologies (DHTs) as “systems that use computing platforms, connectivity, software, and/or sensors, for health care” and …

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NAMSA Medical Device Contract Research Organization

WEBDriven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is a medical CRO offering only the most proven solutions to move your medical device …

Category: Medical Go Health

FDA Updates the Recognized Consensus Standards Database with …

WEBThese have since been added to the latest update of the Recognized Consensus Standards database, known as “List 60,” and include: New sterilization …

Category: Health Go Health

Health Canada and FDA eSTAR Pilot NAMSA

WEBA statement that the medical device will be submitted within six (6) months of acceptance in the eSTAR pilot to both Health Canada (specify if new or significant …

Category: Medical Go Health

Our History NAMSA

WEB1968. Sportol® biological indicators were developed, the first of many in a line of sterility assurance products. 1970s. 1971. The founding name of ‘Science Associates’ was …

Category: Health Go Health

NAMSA Acquires German-Based CRI to Expand Clinical Research …

WEBTOLEDO, OHIO and MUNICH, GERMANY – BUSINESSWIRE—JULY 18, 2023—NAMSA, a world-leading MedTech Contract Research Organization (CRO) …

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510(k) EO Sterility Change Master File Program NAMSA

WEBUnder the Pilot Program, the sterilization provider compiles and submits a Master File to the FDA and, in the event the MAF is accepted and the 510 (k) holder is …

Category: Health Go Health