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Medical Device Single Audit Program

MDSAP is developed by the International Medical Device Regulators Forum (IMDRF). 

What is it?

This program aim to allow Auditing Organizations (AO) to conduct a single audit on a medical device manufacturer that will satisfy the relevant requirements from participating jurisdiction.

The participating Jurisdiction are:

  • U.S. Food and Drug Administration (FDA)

  • Therapeutic Goods Administration of Australia (TGA)

  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)

  • Health Canada (HC)

  • Japan’s Ministry of Health, Labour and Welfare, and theJapanese Pharmaceuticals and Medical Devices Agency (MHLW)

We provide these additional services to maintain Medical Device Single Audit Program

  • Conduct internal audit

  • Conduct audit to critical supplier

  • Support external certification/surveillance audit

  • Conduct gap analysis and closure on QMS

  • Provide regulatory strategy report

  • Ad Hoc Consultancy on Quality, Risk Management & Regulatory

Get in touch with us.

Our consultants at QuikQuality possessed the knowledge to help manufacturers comply with multiple regulatory requirements without wasting excessive resources. Contact us for more information.

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