MDSAP (Medical Device Single Audit Program) Consulting

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

Medical device regulatory affairs and quality assurance (RA/QA) Consulting and Training from QSG deliver the skills and knowledge you need to comply with global requirements and improve your organization’s performance. QSG offers a complete medical device RA/QA consulting and training curriculum. Our courses cover the key medical device sector regulations and show students how to develop processes that satisfy these requirements.

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.

MDSAP requirements align with ISO 13485 along with supplemental QMS requirements in participating markets. You can leverage MDSAP certification to meet regulatory requirements in five major markets:

Audits are conducted by MDSAP-recognized Auditing Organizations (AOs) in a three-year cycle. Your selected AO will conduct an initial certification audit followed by annual surveillance audits. After three years, your AO will conduct a recertification audit.

Identifying your MDSAP certification scope

Manufacturers only need to apply for MDSAP certification in countries where they currently (or plan to) market their devices. However, it’s important to consider your current compliance requirements and your long-term objectives when defining the scope of your MDSAP certification effort.

Internal and gap audits to MDSAP requirements

QSG is uniquely qualified to assess your quality system for MDSAP audit readiness. We are experts in ISO 13485 implementation and auditing and can identify the steps you must take to obtain MDSAP certification.

QSG can perform independent audits to determine your company’s conformity or nonconformity to ISO 13485:2016 and the quality and regulatory requirements of Australia, Brazil, Canada, Japan, and the US.
Please contact us for more information about how we can help you leverage MDSAP certification to meet quality requirements in major markets around the world.

QSG can support your organization with Risk Management, Change Control Program, FDA 483 Response Support, Process Validation, and 510(k) submissions.

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