ISO 15189:2012 Certification for Medical Testing Services in India

ISO 15189:2012 Certification for Medical Testing Services in India

American Global continues to serve companies in a variety of industries and locations.
AGS has recently certified (ISO 15189:2012) a company in the medical testing services industry located in India.

ISO 15189:2012

Medical testing services in the field of biochemistry, immunochemistry, molecular diagnostics, hematology, microbiology, serology and clinical pathology. 


Growing health and wellness advocacy helps deliver an optimistic future for the medical device testing industry. Steady growth is expected this coming decade with a large portion of this growth coming from developing countries and their growing health and wellness markets.

Medical devices require approval prior to launching commercially in the market. USA follows the FDA guidelines while in India they follow CDSCO and Europe considers CE approval. Accuracy in equipment and skilled personnel is critical to managing the regularity of such complex procedures.

Medical devices are classified into six types:

  • Consumables and disposables including syringes and needles.
  • Diagnostic imaging includes MRI, X-Ray, Ultra-sounds, etc.
  • Dental Products such as dentures, braces, etc.
  • Orthopaedics and Prosthetics including knee implants, artificial joints, etc.
  • Patient aid such as hearing aids, pacemakers, etc.

Ensure the success of your medical device with AGS certification! Discover the benefits of AGS certification and start your virtual certification process now. Don’t miss out on the opportunity to grow your business and thrive in the growing health and wellness market. Get certified with AGS today!”