Medical Device Regulations & Compliance
How To Implement Continuous Process Monitoring Of Validated Processes
It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).
This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.
WHITE PAPERS & CASE STUDIES
Connecting The Dots Between Quality, Engineering, And Regulatory To Increase Innovation And Improve Operational Efficiency
The success of medical device companies relies on their ability to produce innovative products while focusing on the need to meet strict regulatory requirements, facing the demands of competition and time-to-market pressures, as well as reducing costs as much as possible. This article presents a Single Source of Truth (SSOT) solution for all device-related information so that all stakeholders have access to relevant information at any time. By controlling information and making it accessible across an organization, teams can focus on quality, accelerate innovation, and improve operational efficiency while ensuring global regulatory compliance.
It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. These critical processes are needed to reach and maintain the optimum operating space while providing the overall value that customers seek. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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.
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.