Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

  • EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused

    The EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in the safety profiles of products.

21 CFR 820's New Terminology & Country-Specific Terms For Medical Device Quality

The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.

5 Key Steps For FDA Q-Submissions

Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

FDA Issues Guidance On Initiation Of Voluntary Recalls

This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

Peru’s Growing Medical Device Market In Latin America

With a population of 32 million, Peru is the fifth most populous country in Latin America. Its medical device market is $390 million, and it imports more than 97% of the medical devices that it uses. This article covers Peru's health system, its medical device regulatory framework, and opportunities for medical device imports.

WHITE PAPERS & CASE STUDIES

How Effective Training Management Can Help You Prevent Quality Issues

Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.

Medtech Manufacturing: From Disruption To Evolution

Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

Vital Signs Of The Medical Device Industry

The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

Why Automation Is Essential For Document Control Compliance

In medical device development, speed, efficiency, and accuracy with document control processes are a top priority.  Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.

LATEST HEADLINES

  • Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark
    2/15/2018

    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
    2/15/2018

    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
    2/5/2018

    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
    1/3/2018

    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
    12/20/2017

    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
    11/13/2017

    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
    10/27/2017

    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
    10/24/2017

    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
    10/6/2017

    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
    10/6/2017

    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.