TopQualityEngineering | About Us

About Us


Top Quality Engineering provides Medical Device and Combination Product companies world-wide with Regulatory Compliance, Quality Management and Training services.

At Top Quality Engineering, we have developed a global diverse team of industry experts with experiences in the highly-regulated industry of Class II and Class III Medical Devices and Combination
Products. Our staff comes from large prestigious Medical Device / Combination Product companies and
successfully acquired startups.

We have partnered with companies in:

  • Developing Quality Management Systems (QMS)
  • Conducting Internal Audits in preparation for Notified Body audits
  • Performing Supplier External Audits
  • Developing and maintaining Employee Training database
  • Transitioning to ISO 13485:2016

The hallmark of Top Quality Engineering is our staff, consisting of:

  • Lead Auditors from European Notified Bodies
  • Certified Quality Auditors (CQA)
  • Certified Quality Engineers (CQE)
  • Engineers
  • Professional Engineers (PE)

The variety of backgrounds allows us to provide you the most efficient collection of services, helping you achieve your business and innovation goals.