The Medical Device Single Audit Program (MDSAP) is a standardized, global approach to auditing and monitoring medical device manufacturing developed by a group of medical device regulators. This program will allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will reduce the inspection burden from multiple markets, including USA, Canada, Brazil, Japan and Australia. Beginning January 1, 2019, Health Canada will cease inspections and rely solely on MDSAP Certification.
Given the costs and commitments that come with the MDSAP, it’s critically important to prepare for success before auditors arrive. One of the most effective ways to ensure readiness for the initial audit is by performing a preliminary preparatory audit. This should be led by an objective, experienced third party consultant with intimate knowledge of program requirements and regulator expectations to ensure your quality system is fully prepared to meet expectations under the new program. If you engage an authorized MDSAP auditor for this initial assessment, their results can be used as part of the assessment even if you know you aren’t anywhere near ready.
If your company is participating or considering participating in the MDSAP, our experienced auditing professionals can assess your current processes against the MDSAP requirements and help you identify and remediate key areas while training staff to maintain compliance under MDSAP. As an auditing and remediation resourcing organization independent of certification or regulatory bodies, this preparatory audit enables you to assess and remediate your system confidentially.
Our experienced MDSAP auditors use the same MDSAP process-based audit model that the Auditing Organizations (AO) will use in order to calculate your MDSAP audit score and identify your areas of biggest risk. Many clients choose to include an assessment of their quality system against ISO 13485:2016 in addition to the MDSAP requirements to allow for a more comprehensive evaluation.
We recognize the challenges of developing and managing an effective quality system under the watchful eye of regulators. Our quality system resourcing professionals draw on years of experience and highly specialized skills to ensure objective, accurate, and actionable recommendations are made each step of the way.
Our proprietary talent selection process brings together a diverse array of skill sets, experience, and expertise to offer a truly unique opportunity for companies interested in receiving personal and professional attention.