Hello and welcome. Thanks for visiting the website.
Advanced Quality System Solutions was founded in 2007 by Michelle Johnston, an experienced RA/QA professional. This 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 range of clients—from global medical device companies to a one-person company working out of a garage. And lots of companies in-between. Their products range from high risk cardiovascular 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. To boot, the regulatory landscape has changed dramatically over the last 6 years with the release of ISO 13485:2016, the introduction of the MDSAP (Medical Device Single Audit Program) as well as the EU Medical Device Regulation (2017/745) which came into effect in May 2021. 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. In 2018, FDA announced their intent to harmonize the QSR with ISO 13485:2016. Although the timeline was disrupted by COVID, FDA’s proposed rule for the Quality Management System Regulation was published in Feb. 2022, followed with a comment period by industry. We should see the final rule soon.
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. Consulting work can be done on-site, remotely, or a combination thereof according to your business needs.
We look forward to working with you.
Michelle M. Johnston, RAC, ASQ Certified Medical Device Auditor