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What would be the use of immortality to a person who cannot use well a half an hour? - Ralph Waldo Emerson
Product Consulting, Medical Devices : General
 
  1. What is medical Devices?
    A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as detailed below. The medical devices are included in the category Medical technology.

    Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, blood sugar meters, and X-ray machines.

  2. Why certification for medical Devices ?

  3. Which product can go for medical Devices ?
    Product range includes Medical Devices for Infusion Therapy, Gastroenterology, Urology, Anesthesia and Surgery.
      Major products are
    • Infusion Sets (I.V. Sets)
    • Blood Administration Sets
    • Scalp Vain Sets
    • Blood Collection Sets
    • Pediatric Sets
    • Infant Feeding Tubes, Suction Catheters
    • Urine Bags
    • Cord Clamps etc.
  4. Why are medical devices or drugs used off-label?
    nothing inherently wrong with this. Doctors may discover that a device or drug can be beneficial in more instances than just those the FDA evaluated when it was first developed.

    Once a drug is approved in the United States (and in many other countries), it can legally be used by doctors to treat any condition or disease a doctor determines is medically appropriate. Some common off-label drug uses include:

    Treating a disease other than the drug is approved for

    Giving a drug at a different dose or frequency than it's been approved for

    Using a drug to treat children when its approval is limited to adults

    Off-label prescribing is typically done for drugs that are older and have been on the market awhile; generic drugs are commonly used off-label. That's because after a drug has been used awhile, new uses for the drug may have been discovered.

    Cancer drugs are frequently used off-label. A cancer drug is usually not approved to treat just cancer overall. Instead, a cancer drug is usually approved to treat a specific type of cancer, often at a specific stage of the cancer. However, doctors may try a drug on another type, or stage, of cancer and discover it works well. It can then become the "standard of care."

  5. List of medical devices
    • High risk devices
    • Medium risk devices
    • Low risk devices
    • High risk devices

    • High risk devices
      are life supports, critical monitoring, energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure patient or staff. Examples include :
    • Anesthesia ventilators
    • Anesthesia units
    • Apnea monitors
    • Argon enhanced coagulation units
    • Aspirators
    • Auto transfusion units
    • Invasive Blood pressure units
    • Fetal monitors
    • Electrosurgical units
    • Incubators
    • Infusion pump
    • Pulse oxi meters
    • External pacemaker
    • Heart Lung Machine

    • Medium risk devices
      These are devices including many diagnostic instruments whose misuse, failure or absence (e.g. out of service) with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury. Examples include
    • ECG
    • EEG
    • Treadmills
    • Ultrasound sensors
    • Phototherapy units
    • Endoscopes
    • Surgical drill and saws
    • Laparoscopic insufflators
    • Phonocardiograph’s
    • radiant warmers (Adult)
    • Ansiscope - Diabetic diagnostic Device
    • Zoophagous agents (e.g., medicinal leeches; medicinal maggots)
    • Lytic Bacteriophages

    • Low risk devices
      Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Examples include :
    • Electronic thermometer
    • Breast pumps
    • Surgical microscope
    • Ultrasonic nebulizers
    • Sphygmomanometers
    • Surgical table
    • Surgical lights.
    • Temperature monitor
    • Aspirators
    • X-rays diagnostic equipment

  6. Which classification does a Medical Device (MD) fall into?
    A medical device (MD) may be classified as Class I (including Is & Im), Class II a, II b and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body.

    The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules. Classification of a medical device will depend up on a series of factors, including:
    • how long the device is intended to be in continuous use
    • whether or not the device is invasive or surgically invasive
    • whether the device is implantable or active
      whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device
    • A manufacturer may successfully avoid the particular higher classification by clearly define on the labeling the Intended Purpose in such a way that the device falls into the lower class
  7. Medical device CE Marking procedures
    Depending on the individual case, each Medical Device manufacturer must choose its own and most suitable conformity module(s) which address (es) its particular product categories and business needs.
    • Steps to obtain CE Marking for your Medical Devices
    • Assist you in identifying all EU Directives applicable to your product.
    • classifying your device.
    • selecting the most appropriate conformity assessment module.
    • selecting your Notified Body, if your chosen conformity module requires so, to perform the third-party conformity assessment tasks.
    • Assessing your device according to Essential Requirements.
    • preparing the "Technical File".
    • preparing your "Declaration of Conformity".
    • You affix the CE Marking on your device and start to sell.
    • EU Authorized Representative Service AFTER you have affixed CE Marking on medical device

    • your Auth Rep for vigilance and inspection purpose while your CE-Marked devices are placed on the European market by you directly or through your local European distributors. Our service mainly covers the follows:

    • Publish Your Device: At webpage for third party verification
    • Product Registration:
      If applicable, we can register your product in EU and get your product a Certificate of Registration.
    • Renewal and Update Product Registration:
      The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration
    • Keep Your Technical Files:
      We store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.
    • Legislation Monitoring:
      We monitor and report on new developments in European product legislation relevant to your products.
    • Vigilance and Incident Reporting:
      We assist with product vigilance and incident reporting.

  8. What are the advantage of Medical device

  9. Medical device important links
    Medical services directive (MDD: 93/42/EC)

  10. Downloads & images

  11. Please email us on customer.care@netpeckers.net for further details
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