Medical Device Regulations & Compliance
India Aims To Boost Medical Device Industry With New Initiative
India's government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a "Sunrise Sector." The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit.
In the medtech industry where time and regulatory compliance are crucial, optimizing and digitalizing your labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers in the EU.
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?
Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.
WHITE PAPERS & CASE STUDIES
Performance Test According To Chapter <41> Of The USP
This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.
In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.
This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.
This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.
A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.
Medtronic’s InterStim Micro Neurostimulator, InterStim SureScan MRI Leads Gain CE Mark1/13/2020
Medtronic plc (NYSE:MDT) today announced it has received CE Mark for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads — clearing the technologies for commercial sale and clinical use in Europe.
FDA Clears Medtronic’s Stealth Autoguide System For Cranial Procedures12/18/2019
Medtronic plc (NYSE:MDT) announced that the U.S. Food and Drug Administration (FDA) recently cleared the Stealth Autoguide™ system, the first cranial robotic platform that integrates with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution.
Medtronic Submits InterStim Micro Neurostimulator And SureScan MRI Leads For FDA Approval10/7/2019
Medtronic plc (NYSE:MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads.
FDA Grants Breakthrough Designation To SoniVie’s TIVUS System To Treat Pulmonary Arterial Hypertension9/6/2019
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients with PAH.
Orchestra BioMed’s Cardiac Neuromodulation Therapy Device For Hypertension Earns CE Mark9/4/2019
Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.
FDA Clears Dominion Aesthetic Technologies’ Non-Contact Body Sculpting6/25/2019
Dominion Aesthetic Technologies, Inc. recently announced that it has received FDA clearance for its body contouring product, eon FR, which is a non-contact medical device that reduces fat.
FDA Clears Itamar Medical’s Fully Disposable Home Sleep Apnea Test6/6/2019
Itamar Medical Ltd. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for WatchPAT One, the latest innovation of its WatchPAT technology and the first and only fully disposable Home Sleep Apnea Test (HSAT).
FDA Approves BD’s First Venous Stent To Treat Iliofemoral Venous Occlusive Disease3/14/2019
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo™ venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.
CurvaFix Receives FDA 510(k) Clearance For CurvaFix Rodscrew3/5/2019
CurvaFix, Inc., a developer of medical devices to repair bone fractures in orthopedic trauma patients, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CurvaFix® Intramedullary Rodscrew. CurvaFix’s patented solution has the potential to improve outcomes and enable a less invasive approach in pelvic trauma surgery.
FDA Clears Medtronic’s Accurian RF System For Nerve Tissue Ablation2/27/2019
Medtronic plc recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Accurian(TM) RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues.