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Aegis LifeSciences Pvt. Ltd. - "MDSAP Certified"

Auditing and monitoring the manufacturing of medical devices to improve their safety and Quality

Aegis LifeSciences has successfully obtained the MDSAP certification for all 5 participating countries (Australia, Japan, USA, Canada and Brazil) proving its consistency and growth aligning with the best Quality management systems for Medical device manufacturing.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Contact Aegis LifeSciences for more information:-

bd@aegis-lifesciences.com

Details

  • Ahmedabad, Gujarat, India
  • Pinak Saini