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Product Consulting, Active Implantable Medical Devices
 
  1. What is Active implantable medical Devices?
    'Active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

    'Active implantable medical device' means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

  2. Why certification for medical devices (AIMD) ?

  3. How does a manufacturer comply with requirements?
    The manufacturer’s products must meet all of the relevant Essential requirements contained in Annex 1 of the Directive.

    This will include amongst others, as relevant :
    • Risk management
    • Clinical data
    • Sterilization
    • Biological safety
    • Electrical safety
    • Electromagnetic compatibility
    • Labeling and Instructions
    Manufacturers will also normally have to have in place a quality system which meets the(Medical devices. Quality management systems. Requirements for regulatory purposes).

    Before manufacturers can place their products on the market they will also need to have their quality systems and technical documentation reviewed by a Notified body (link to NB section). The body will need to assure itself that all relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate their compliance with the requirements.

  4. Step to Achieve Certification (AIMD)

  5. What are the advantage of Active implantable medical Devices ?

  6. Which product go for a Active Implantable Medical Device (AIMD)?
    An Active Implantable Medical Device (AIMD)

    Is defined in AIMDD Directive (90/383/EEC) as:
    "Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure".

    According to the directive, a device is ‘active’ if it relies for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. This includes, for instance, devices activated by means of pressure, unless this effect is achieved by energy resulting from the patient’s body. The definition implies that the function of the device involves using the source of power to perform useful work. Mere transmission of heat, light, pressure or vibration does not mean that a device is active.

    Examples of types of devices normally covered by this directive include:
    • implantable cardiac pacemakers
    • implantable defibrillators
    • leads, electrodes, adaptors for the above
    • implantable nerve stimulators
    • bladder stimulators
    • sphincter stimulators
    • diaphragm stimulators
    • cochlear implants
    • implantable active drug administration devices
    • catheters, sensors for active drug administration devices

  7. Important links for AIMD
  8. Downloads & images for AIMD

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