A midpoint review of the Medical Device Single Audit Program (MDSAP) pilot shows that while the initiative is meeting or is on track to hit many of its goals, device companies' interest in participating is lagging.
An evaluation of the Medical Device Single Audit Program (MDSAP) pilot has shown that the program is meeting many of its goals.
That should be good news for industry, since the point of the pilot program is to demonstrate that MDSAP-approved auditors can successfully audit medical device manufacturers while checking off the regulatory requirements of the five participating countries: Australia, Brazil, Canada, Japan, and the United States. This should logically lead to fewer repetitive regulatory audits for companies.
But a major sticking point for the pilot program, which is at the halfway point between its start in January 2014 and its expected completion at the end of 2016, is securing enough participation from medical device manufacturers. The "Mid-Pilot Status Report" explains only 45 manufacturing sites had raised their hand to participate as of July 23, 2015. That's far short of the pilot's proof of concept criteria (PoCC) goal of attaining a 10% participation level—about 330 manufacturing sites. According to the report, "Program participation by medical device manufacturers appears to be the primary challenge at the mid-pilot review. Manufacturer participation is vital for the success of the program." [emphasis in the original]
One potential factor for low industry interest may be the number of auditing organizations that are authorized to perform MDSAP audits. As of the evaluation, there were six organizations with this authorization and seven more waiting to qualify. One bright note is the jump in participating device manufacturer sites in July 2015, with 20 new sites requesting participation that month, increasing the total number of sites from 25 to 45. As explained in the report, "As more auditing organizations (AOs) become authorized to conduct MDSAP audits, a continuation of the positive slope is anticipated."
There are eight proof of concept criteria for the pilot, including four that have met or are expected to meet their goals and four (one of which is industry participation) that need more data or analysis. Criteria that have met goals so far include:
- "whether the audit model and task sequence appropriately assesses quality management system (QMS) and regulatory requirements"
- "whether the assessment model and task sequence appropriately assesses MDSAP requirements"
- "whether time provided in the audit duration model is suitable for evaluating and recording evidence of conformity / nonconformity with requirements"
One criteria that is on schedule to meet its goal:
- "whether a sufficient number of candidate AOs are recognised"
The four criteria that can't yet be assessed for ability to meet the goals:
- "whether the format and content of audit and nonconformity reports comply with prescribed requirements"
- whether the evidence provided in audit and nonconformity reports, for common QMS requirements, supports the findings and nonconformity grades"
- "whether audit and nonconformity reports would substantiate regulatory decisions"
- "whether a sufficient number of manufacturers participate in MDSAP"
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|Learn about trends in medical design innovation at the MD&M Philadelphia conference , October 7–8, 2015.|
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