Given the costs and commitments of certification through the Medical Device Single Audit Program (MDSAP), it’s critically important to prepare for success before auditors arrive.
One of the best ways to ensure readiness for the initial audit is by performing a preliminary preparatory audit. Ideally, this would be led by an experienced third party consultant with intimate knowledge of program requirements and regulator expectations, along with firsthand experience in the field helping other companies prepare.
We’ve summarized the anatomy of a MDSAP preparatory audit to offer a peek inside the process and what to expect if your organization intends to prepare for Notified Bodies prior to their arrival.
A MDSAP prep audit begins with a review all SOPs currently in place––essentially mirroring a real initial MDSAP audit, which we've highlighted in the MDSAP audit cycle below.
During this in-depth documentation review, problematic or missing elements would be redlined for revision, which could be handled either internally or by the third party expert.
Following a comprehensive documentation review, an on-site gap assessment is performed to the MDSAP as well as any other standards (ISO, FDA, etc.) the manufacturer would like to evaluate to.
Again, all issues would be redlined with clear direction on how to resolve them.
Training is one of the most important tasks in the lead up to a MDSAP audit. In line with the new expectations presented in ISO 13485:2012, demonstrating your staff are "trained" is no longer enough. Notified Bodies will now be expecting personnel to demonstrate competence.
ISO 13485:2016 carries over the same dimensions for competency as the earlier version (education, training, skills, and experience), and still requires manufacturers determine the necessary competence for those who perform work that affects product quality. However, the 2016 standard introduces a number of additional requirements:
• Document the process for establishing competence
• Document the process for providing needed training
• Provide training or take other action to achieve or maintain the competence needs
• Develop a methodology to check effectiveness that is proportionate to the risk associated with the work performed
Training and instruction from an experienced third party consultant offers valuable insights for both inexperienced and experienced quality professionals in the lead-up to MDSAP certification.
During the preparatory audit, third party consultants become valuable training resources by offering fresh perspectives into new approaches and successes from prior engagements, especially for those who find themselves stuck in myopic mindsets or blind to new opportunities.
There’s rarely only one path toward compliance. Consultants not only help companies be more efficient, but also lead the effort in training staff to bring those new approaches to life within their organizations.
In the simplest terms, a MDSAP preparatory audit enables companies to lean on the experience of a third party expert to review current procedures and determine an overall state of compliance.
When gaps are identified, these experts lay out exactly what must be done to bring the organization into compliance––applying this assessment throughout the quality system.
Following this comprehensive review, a report is generated which details, line-by-line or section-by-section, what is out of compliance and what must be changed to resolve the issues––documenting all gaps along the way.
In addition to a clear, actionable report, consultants can also develop a risk-based plan to compile the actions companies must take and prioritize them according to risk level. If complaint handling deficiencies exist, for example, these problems will likely rise directly to the top of the task list as these issues often prompt warning letters and other enforcement actions when observed.
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The initial MDSAP audit is essentially a test for certification readiness given by a Notified Body. Manufacturers that aren’t given the green light in this initial stage will be forced to find time on an already-booked audit schedule, which now extends years into the future.
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By conducting an initial preparatory audit, medical device manufacturers can ensure they are adequately prepared for MDSAP––and further, resolve any issues before a Notified Body arrives, thereby setting the stage for an efficient and ultimately successful certification.
Interested in working alongside experienced quality professionals with firsthand experience preparing medical device manufacturers for the Medical Device Single Audit Program? Contact us today or download our free white paper below to learn more.