MDSAP Audit Services

What is an MDSAP Audit?

MDSAP was conceived in 2012 by the International Medical Device Regulators Forum, which recognized the benefits of reducing compliance costs and approval timelines in medical device manufacturing, potentially leading to reduced overall healthcare system costs. From 2014 to 2017, the five national agencies piloted the single audit program and produced a report with positive results indicating, “the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.”

The US FDA now “accepts MDSAP audit reports as a substitute for routine Agency inspections.” Participating medical device manufacturers have responded positively, saying, for example, that the program “has allowed us to consolidate the global regulatory assessment process across multiple international locations, reducing internal costs while increasing the overall predictability of these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering the safest, most effective and technologically advanced products possible.”

MDSAP also benefits regulators, since multiple national agencies do not have to deploy inspectors to the same company on the other side of the planet to perform a largely similar audit. Its requirements are aligned with ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes), the audit structure is similar to FDA’s quality system inspection method, and a risk-based approach is emphasized. Regulators also benefit by aligning their regulatory approaches, improving the consistency and predictability of their audit programs, and avoiding deploying resources in a duplicative way.

An MDSAP audit is conducted by an independent third party to verify compliance with the regulations of one or more of the five participating countries. This demonstrates to current and future clients that the supplier has the systems in place to produce safe and effective medical devices. A third-party audit provides objectivity that a self-examination or a client audit cannot.

MDSAP is based on a three-year audit cycle:

• An initial audit is a complete audit of the medical device manufacturer’s QMS.
• A surveillance audit is conducted in year 1.
• Another surveillance audit is conducted in year 2.
• A recertification audit is conducted in year 3.

Request a quote

Pro QC’s MDSAP Audit Outcomes

Solid pathway to compliance

MDSAP requires a definitive audit cycle from an approved “MDSAP Auditing Organization.” Pro QC International provides MDSAP audits to identify noncompliance and provides CAPA plans. We support our clients in ensuring they comply with the requirements of MDSAP before this definitive audit sequence begins.

Audit report delivered within 72 hours after the service

Pro QC clients can expect an organized MDSAP audit report delivered within 72 hours after the service and presented in exhaustive detail. Each report provides:

• A summary of the audit
• The overall audit score and compliance level with MDSAP
• The compliance level for each part of the regulations. Each finding is explained in clear language and is color-coded.
• The recommended corrective actions to implement
• Objective evidence such as photos, interviews, and examined records and documents

Corrective action plan

The MDSAP audit is only the first step. If the compliance level is subpar, a corrective action plan should be developed and implemented to effectively improve the QMS performance sustainably. Pro QC helps the audited organization reach full compliance by:

• Performing an MDSAP audit
• Establishing a corrective action plan
• Verifying corrective action implementation through detailed follow-up activities
• Controlling performance and facilitating continuous improvement.

Request a quote