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.