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Medical Device Newsletter

  • 18 December 2018

    Health Canada issues draft guidance on Premarket device cyber security
    In order to help the manufacturers of the medical device in adhering to premarket cyber-security requirement, Health Canada posted new draft guidelines on Friday.
    Sale and distribution of Essure device to be discontinued in US by Bayer
    Pharmaceutical company Bayer has decided to stop selling its birth control product Essure in the US after 31st Dec 2018. US FDA imposed restriction on the marketing of the device on Bayer in April this year due to inadequate risk information and other requirements to ensure the device’s safety and effectiveness. However according to Bayer,”
    Pre-market approval by FDA given to Strykers flow diverter
    A Stryker is a medical technology company which has obtained pre-marketing approval from USFDA for the use of its Surpass Streamline Flow Diverter in treating unruptured large and giant wide-neck intracranial aneurysms. Surpass Streamline is already marketed in other international countries and is the second such device to get USFDA approval.
    Surgical Guidance Firm Endomag has received USFDA approval for breast cancer device called Magtrace
    Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag. Currently breast cancer is treated through surgical removal of tumor and then a lymphatic mapping procedure to determine whether or not the cancer has spread to other parts of the body which usually involves the use of radioactive drugs and blue dyes having limited availability.
    AstraZeneca collaborates with Geisinger to develop an app for Asthma care
    Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag.
    USFDA approval given to Medtronics less invasive approach to implant LVAD
    Medtronic is a global medical device company based in Dublin, Ireland providing medical technology, services and solutions. The company has received USFDA approval for its less invasive implantation procedure of the left ventricular assist device (LVAD) called HeartWare HVAD system. This will be helpful in cases of advanced, refractory hear failure patients.

    13 July 2018

    510(k) clearance to medical device company Embolx's pressure-directed arterial embolisation system granted by USFDA
    The embolisation therapy facilitates the delivery of drugs and embolic agents to the targeted treatment areas thereby protecting the surrounding healthy tissues.
    USFDA approval given to Zephyr Endobronchial Valve System developed by Pulmonx
    Zephyr Endobronchial Valve System has been designed by Pulmonx (an interventional pulmonology treatment provider) to treat severe emphysema, a type of chronic obstructive pulmonary disease (COPD).
    iStent inject Trabecular Micro-Bypass System developed by Ophthalmic medical technology company Glaukos received FDA approval
    Glaukos is an Ophthalmic medical technology company which has got the US Food and Drug Administration (FDA) premarket approval (PMA) for its iStent inject Trabecular Micro-Bypass System for the use of the system to decrease intraocular pressure (IOP) in adults with mild-to-moderate primary open-angle glaucoma (POAG) and undergoing concomitant cataract surgery.
    USFDA approval given to Eversense Continuous Glucose Monitoring (CGM) System of Senseonics
    Premarket Approval (PMA) application by USFDA has been granted to Senseonics Holding's Eversense Continuous Glucose Monitoring (CGM) System which is designed for diabetes patients. According to the company’s president and CEO Tim Goodnow," The FDA approval will allow to make Eversense available in the US, as it is available already in many European markets."
    Improvement in atrial fibrillation diagnosis observed with the use of home based ECG patch
    In almost 20% of individuals experiencing a stroke due to AFib, the occurrence of AFib is not diagnosed until the time of their stroke or shortly afterward. However if AFib can be recognized early then there can be an absolute risk reduction in all strokes of 2.7% per year for primary and 8.4% per year for secondary prevention, as well as a 0.5% per year absolute risk reduction in mortality.

    14 June 2018

    Regulation-on-ultrasound-machine-and-other-imaging-machines-to-be-made-more-strict-by-the-government-of-India
    It has been decided by the government of India to make the regulations more strict for ultrasound machines and other imaging equipments to prevent import of these equipments without proper registration.
    New medical device guidelines to contribute to 25-50% of the cost of medical devices procured by the government
    According to the proposal by the Department of Pharmaceuticals, domestically sourced components have to contribute to 25-50% of the cost of medical devices procured by the government.
    Optovue's OCTA blood vessel measurement technology approved by USFDA
    510(k) clearance from the US Food and Drug Administration (FDA) has been given to the AngioAnalytics, world’s first optical coherence tomography angiography (OCTA) blood vessel measurement technology to firm Optovue.
    A new minimally invasive medical device called Therepi developed to deliver medicine directly to heart
    A team of researchers including researchers from Harvard University and Massachusetts Institute of Technology (MIT) and National University of Ireland (NUI) Galway have developed a new minimally invasive medical device called Therepi that can be sutured onto diseased heart tissue to continuously deliver required drugs, proteins or stem cells.
    New test system launched by Abbott in US for management of Diabetes.
    New Afinion 2 analyser ,a rapid multi-assay platform to provide optimized and simplified results that are accurate and actionable at point-of-care has been launched in US by Abbott for Diabetes management.