Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

  • Data: The Near Future Of Regulatory Info Management In Europe

    Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

How To Navigate Patent Eligibility Of AI-Driven Diagnostics

The uncertainty in patent eligibility has had a chilling effect on patenting life sciences and computer software inventions. AI-driven diagnostics that lie at the intersection of these two fields face particular difficulty. This article shares tips from attorneys on how diagnostics companies can tackle their patent eligibility questions with more confidence.

ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs

Read the FAQ´s and learn for example what the revision of ISO contains and the differences with previous version. 

Tips For Obtaining Your 510(k) FDA Clearance

This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the pre-submission process, responding to FDA rejection of your application, and more.

The Shifting Data Privacy Landscape For Femtech & Beyond

The lack of an overarching privacy framework for all health data has resulted in a wild west of privacy practices, with some health tech companies prioritizing consumer privacy while other companies do not. The leak of the U.S. Supreme Court’s draft decision in Dobbs v. Jackson Women’s Health Organization has reignited demand for privacy standards. This article examines what this means for femtech and health tech at large.

WHITE PAPERS & CASE STUDIES

The Future Of The FDA: Operating In An “Electronic World”

Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management

This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.

Steps To Successfully Complete An FDA Inspection

We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

How Early Raw Material Testing Mitigates Product Development & Regulatory Risk

Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.

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.