Here’s How To Prepare For An ISO 13485 Audit

Congratulations! You have been chosen (or perhaps conscripted) to conduct or participate in an ISO 13485 internal quality management system (QMS) audit. For many, the prospect of coordinating and conducting an audit can be terrifying. However, believe us when we say the terror subsides with each hour of planning you do. In this white paper we will talk about how you can lay the foundation to ensure that your ISO 13485 audit progresses smoothly, yielding input that’s useful to your company’s […]

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The MDSAP Audit Model: What to Expect and How to Prepare

Unless you’ve spent several years adrift on a raft in the South Pacific, you’ve probably heard about the Medical Device Single Audit Program, known as MDSAP. At Oriel STAT A MATRIX, many of our medical device clients ask us about the program, how to prepare for it, and how an MDSAP audit differs from a typical ISO audit or FDA inspection. Before we get into that, let’s take a step back. What is MDSAP? The Medical Device Single Audit Program […]

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MDSAP Mock Audits – Getting QA and RA on the Same Page

As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the like. As companies grow, the scope of responsibilities narrows and people in QA and RA don’t interact as much as they should. That’s about to change and it’s being driven by one thing: MDSAP. As you may […]

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MDSAP’s Process-Based Audit Approach

Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.

Short-Term Pain = Long-Term Gain The MDSAP audit model uses a process-based approach and defines the required audit sequence, nonconformity grading, scoring mechanism, and time requirements per process. In addition, the auditors must examine regulatory requirements from multiple countries. While the MDSAP audit may be more difficult at first, the payoff is big: A single audit satisfies multiple regulatory authorities. MDSAP’s Process-Based Audit Approach MDSAP’s process-based approach is different from the traditional checklist-style audit that reviews documentation and conformance to […]

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