medical devices


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Medical devices industry

A medical device is a broad term that encompasses a wide range of instruments, apparatus, machines, or implants used for medical or diagnostic purposes. These devices are designed to diagnose, prevent, monitor, or treat medical conditions, enhance the function of the body, or investigate and replace anatomical structures.

Medical devices play a crucial role in the field of healthcare and are used in various settings, including hospitals, clinics, laboratories, and even in home healthcare. They can range from simple, non-invasive devices like thermometers and blood pressure monitors to complex, implantable devices such as pacemakers and artificial joints.

Medical devices can be categorized into different classes based on their risk level, and the regulatory requirements for these devices may vary accordingly. The classification typically considers factors such as the intended use of the device, its duration of contact with the body, and the invasiveness of the procedure involved in its use.

Examples of medical devices include:

  1. Diagnostic Equipment: X-ray machines, magnetic resonance imaging (MRI) machines, blood glucose meters, and pregnancy test kits.
  2. Monitoring Devices: Blood pressure monitors, heart rate monitors, and pulse oximeters.
  3. Therapeutic Devices: Insulin pumps, nebulizers, and hearing aids.
  4. Surgical Instruments: Scalpels, forceps, and surgical lasers.
  5. Implantable Devices: Pacemakers, artificial joints, and cochlear implants.
  6. Assistive Devices: Wheelchairs, prosthetics, and orthopedic braces.

Medical devices undergo rigorous testing and evaluation to ensure their safety, effectiveness, and compliance with regulatory standards before they are introduced into the market. Get your approval now and apply for the certification at bqs.

New regulations and standards are developing continuously in order to assure safety over medical devices producing around the world. regulation of medical devices and in vitro medical devices market will never be less strict than today. Choose bqs as your accredited certification and notified body for assessment and auditing process and prove regulators and your customers your products, certified by bqs are safe for our daily use.

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IVDR 2017/746

In Vitro Diagnostic medical devices

MDR 2017/745

Medical devices

ISO 13485

Accredited quality management system certification according to ISO 13485:2016 standard


EC certification according to the European parliament and council directive 98/79/EC covering In vitro diagnostic medical devices


EC certification according to the European parliament and council directive 93/42/EEC covering medical devices

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