Medical Device Regulations & Compliance
Implications Of COVID-19: EU MDR Implementation Update
Learn how the EU 2020/561 Article 59 update, progress on guidance documents, formation of Expert Panels, and more affect your company.
Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.
Latin America’s largest medical device market is streamlining its registration process and attempting to harmonize with globally recognized standards. Challenges are weighed against opportunities in this article, the first of a two-part series examining the Brazilian medtech market and factors that affect it.
Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.
The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.
WHITE PAPERS & CASE STUDIES
Test Method Development, Experimental Design And Positive Controls For Package Integrity
Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.
Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.
It has been reported that 83,000 deaths and 1.7 million injuries have been linked to medical devices adverse events over the past decade. There is indication that some aspects of both medical device human factors engineering (HFE) design and Food and Drug Administration (FDA) HFE validation criteria may not provide proper methodologies for selecting and testing patient populations, possibly leading to medical devices that pass FDA HFE validation yet still exhibit significant use errors when utilized in the real world. This paper explores the possible sources of HFE performance problems with medical devices and links potential problems to HFE validation methodologies within the FDA HFE guidance framework.
With the EU MDR going into effect in about a year, medical device manufacturers are gearing up to prepare product lines for the massive regulatory changes. The planning and pre-clinical testing necessary for MDR compliance can be an exhaustive, multi-faceted venture.
Warren Stacey, PRISYM ID, examines a single-source approach that could eradicate data duplication, inconsistencies, and costly human error.
Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
Arterys’ Oncology Imaging Suite With Deep Learning Cleared By FDA
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Embrace Becomes First FDA-Cleared Seizure-Monitoring Smart Watch
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
FDA Clears Zimmer Biomet’s Total Shoulder Arthroplasty System
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.
K2M’s 3D-Printed Expandable Corpectomy Cage With Cervical Spine Indications Gains CE Mark
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.
First Wire-Free Radar Breast Tumor Localization System For Long-Term Implant Cleared By FDA
Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.
CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark
CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).
Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed.
FDA Clears Game Ready’s Multi-Modality Recovery Device
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.
FDA Approves Implantable To Treat Central Sleep Apnea
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.