Author: Suzanne Broussard
Take the advice of industry experts and AOs—the key to acing the MDSAP audit is to prepare, prepare, prepare.
The MDSAP audit process is intense in that it is
designed to provide thorough coverage of QMS and multiple jurisdictions
regulations. Remember, your organization already maintains a level of
compliance in all countries they sell devices. MDSAP simply rolls all these
regulatory requirements into an efficient process. Here are a few tips to keep
in mind when preparing for the MDSAP audit.
1. Look closely at the MDSAP Audit Model to determine exactly what the Auditing Organization (AO) will need. The MDSAP Audit Model is the AOs guide. Everything needed for the audit is clearly laid out in this comprehensive guide. Each of the 90 questions the AO will ask is contained in this guide. And, each question is cross-referenced to relevant sections of ISO 13485:2016 and other specific requirements of medical device regulatory authorities participating in the MDSAP program.
2. Use the MDSAP Companion Document to create a gap analysis and perform an internal audit. It is universally agreed by AOs and manufacturers that have been through the MDSAP audit process that the best way to get ready for an MDSAP audit is to use the MDSAP Companion Document as a guideline. The Companion Document further clarifies the Audit Model and provides guidance to the auditors, making this a very handy supplement for manufacturers. MDSAP is very structured, and understanding the specific information that auditors will be focusing on and in which order eliminates any guesswork by the manufacturer.
What can I expect during a MDSAP audit?
3. All documents need to be
organized and available.
The audit is timed. Therefore, the vast volume of documents required need to be
organized and quickly accessible—this is critical for a successful audit. The
AO will not be able to come back and revisit areas in which documents are not
4. Organizations must prove control over their suppliers. The way in which you demonstrate control over your suppliers needs to justified, and these details need to be incorporated into procedures and programs. A manufacture cannot simply say their supplier is ISO or MDSAP certified. The AO wants to know how your organization ensures that the supplier is compliant. Here’s why a global medical device manufacturer should consider the MDSAP.
6. Be clear on what is done where. This aspect is especially important for multi-site manufactures.
Clearly list the scope of activity at each site and which products are covered
by operations. Make sure to define multi-site manufacturing in Stage 1 so the
AO can calculate the appropriate time-frame for Stage 2.
7. Employees must be proven
competent. Providing objective
evidence that employees are competent, not just trained, in regulatory
requirements of all pertinent jurisdictions is mandatory. Objective
evidence could include testing after training and job function checks to assure
competency is practiced—not just learned.
8. Consider the Auditors Perspective. Brian Ludovico, Executive Director at NSF International, suggest
organizations keep in mind the AOs perspectives when preparing for the MDSAP
Audit. He provided a number of additional tips in recent interviews: auditors
cannot read your mind, please justify your work, and regulatory and quality
need to be friends in your organization.
9. Learn From Past Mistakes. Marcelo Trevino,
Senior VP of Regulatory Affairs and Quality Systems at Applied Medical, provides
insights on how to avoid some of the most common mistakes with European
If you are ready to bypass the hassle of multiple regulatory inspections and undergo a single, rigorous audit which satisfies the quality regulation of each jurisdiction, consider transitioning to MDSAP.