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FDA and Canada MDSAP Audit Certification Consulting

The Medical Device Single Audit Program (MDSAP) is a cooperative program between the US FDA, Canada, Brazil, Japan, and Australia. The goal is to lessen the repetitive audit burden placed upon medical device companies by using a single audit to demonstrate compliance in all five countries. Health Canada is leading the way and will require MDSAP certification in January 2019. 

An MDSAP audit differs from a typical FDA inspection or Notified Body audit. The scope of the audit often extends well beyond your quality management system procedures and deep into regulatory compliance. It’s a meandering process-based approach that differs from the checklist-based audits you may have experienced in the past. It is not unusual for an MDSAP audit to be conducted by two auditors plus observers from FDA, Health Canada, and your Notified Body. Preparing for this type of audit takes effort but is worth the time, since one successful audit satisfies all five regulatory bodies.

Our baseline audit will determine your state of readiness for an MDSAP audit

Oriel STAT A MATRIX has helped many medical device manufacturers prepare for an MDSAP audit. The first thing we do is understand your current compliance level against MDSAP requirements. We’ll follow the same approach that the Auditing Organizations (AO) will use and calculate your MDSAP audit score to identify your areas of biggest risk. The baseline audit concludes with a transition planning session. Since we are not an AO, we can make specific recommendations and give you an actionable “roadmap” to resolve any findings.

An MDSAP transition action plan closes the gaps

After we conduct your baseline MDSAP audit, you have two choices: You and your team can implement our recommendations, or Oriel STAT A MATRIX can help you. Additional support may include coaching to apply risk-based thinking, developing and reviewing MDSAP audit checklists, aligning your internal audits to the MDSAP process, assessing if your products are registered properly in the participating countries, and meeting the MDSAP reporting requirements.

Final MDSAP checklist item: Making sure you and your team are ready!

You’ve prepared, and now it’s time for a final run-through before the real event. In this Preassessment Audit, our independent reviewers will follow the Process-Based MDSAP Audit Model and scoring to help you identify any issues before your MDSAP certification audit. This gives you time to plan and implement corrective actions and prepares you for what an actual AO certification audit will feel like. Our 2-day MDSAP training class is also an excellent way to make sure you and your staff are fully prepared for how an MDSAP audit will be conducted.

Contact us today to learn how we can help you prepare for your MDSAP certification.

Select a course below to learn more or to register.
Course Name Public On-site
New!   Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

Medical Device Single Audit Program (MDSAP) FAQs


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