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Advanced Quality System Solutions was founded in 2007 by Michelle Johnston, an experienced RA/QA professional. The mission of Advanced Quality System Solutions is to provide value-added and cost-effective consulting to companies in the medical device industry with needs related to quality system compliance.
Over the years, Advanced Quality System Solutions has worked with a variety of clients from Fortune 100 global medical device manufacturers to a one-person company working out of their garage. And lots of companies in-between. Their products range from life-sustaining devices to non-sterile manual surgical instruments. In each instance, Advanced Quality System Solutions has met or exceeded client expectations. Whether you need a formal quality management system built from the ground up, ongoing QA support, a comprehensive internal audit, QMS training, or preparation for an FDA inspection—Advanced Quality System Solutions is your answer.
Maintaining a compliant and effective quality management system takes work. The regulatory landscape has changed dramatically over the last 4 years with the release of ISO 13485:2016, introduction of the MDSAP (Medical Device Single Audit Program) as well as the extended May 2021 Date of Application deadline for the EU Medical Device Regulation (2017/745). Advanced Quality System Solutions has a 100% success rate in working with clients so that certification is recommended by their 3rd party registrar or Notified Body.
And, let’s not forget 21 CFR Part 820, FDA’s Quality System Regulation (QSR). Changes are coming here as well. FDA announced in 2018 that they will be harmonizing the QSR with ISO 13485:2016. We can expect to see this rolled out in a few years. It is important to note that the QSR and ISO 13485 are not identical so in instances where the QSR contains more stringent requirements, they will likely remain in place. Organizations are encouraged to read AAMI TIR102:2019 MAPPING QSR TO ISO 13485:2016.
Whether your needs are short or long-term, big or small, Advanced Quality System Solutions is here to help. Visit the Services Tab to learn more.
We look forward to working with you.
Michelle M. Johnston RAC