MDSAP Auditors – Medical Device Single Audit Program

MDSAP Auditors - Medical Device Single Audit ProgramWill your medical devices be compliant with MDSAP?

We can provide a MDSAP auditor to perform a pre-inspection audit, highlighting problem areas and giving you time to correct them before your official inspection.

The MDSAP program is a comprehensive approach to quality system auditing. It is being instituted by an international coalition of countries including the United States, Canada, Brazil, Japan and Australia. The coalition is devoted to pooling resources, technology, and services to enhance the safety and oversight of medical devices worldwide. Therefore, the MDSAP program will be beneficial to manufacturers of medical devices who are interested in marketing and selling devices in nearly all markets.

The audit criteria of the MDSAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities. One important provision includes the ability for a manufacturer to exclude the requirements of any jurisdiction in which the manufacturer does not intend to supply medical devices. This means that at a minimum the requirements of ISO 13485 will be included in the MDSAP auditing criteria along with only the applicable regulations of the authorities in which the company intends to sell a device.

MDSAP Auditors will:

  • Provide audits anywhere in the world. We will identify the right auditor that is closest to the site to be audited to keep your expenses low.
  • Can offer scheduled audits or surprise audits.
  • Have an active certification and deep understanding of the relevant best practices.

 

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