• 25 years developing and executing regulatory and quality frameworks for medical devices
  • Experience working within and evolving medical devices in large companies

Heinz Steneberg
Vice President of Regulatory Affairs

Heinz is a seasoned Regulatory Affairs leader with a comprehensive track record of successful regulatory submissions such as IDEs, INDs, BLAs, PMAs, 510(k)s, and EU IVDR Dossiers. He has worked in regulatory, quality, and clinical roles in the medical device and diagnostic industry for over 25 years. His previous leadership roles included Executive Director of Regulatory Affairs & Quality Assurance at Quest Diagnostics, Regulatory Affairs Director at Roche Molecular Diagnostics, Regulatory Affairs Director at Abbott, and Head of Regulatory & Clinical Affairs at Carl Zeiss Meditec. Earlier in his career, Heinz was the Division Manager of TUV Rheinland of North America’s Medical Division, supporting CE Marking projects of his clients in the medical device industry.

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Urology San Antonio

What We Provided:

  • Remote Lab in office urology PCR lab Lab equipment & proprietary validation
  • Training and technical support
  • Reagents and consumables on a recurring basis
  • Lab reports using our proprietary software

How Molecular has helped Urology San Antonio achieve their goals:

  • Lowered costs to lab & patient
  • High- quality patient care
  • Quicker turn around times
  • More accurate lab results

Alan Winkler, Executive Director

New service lines like PCR allow us to better serve the clinical needs of our patients; however, new opportunities come with new challenges.
It has been wonderful to have the expertise of MTL to put in place appropriate clinical resources to operate an efficient, financially-viable PCR lab. Autonomy with expert insight. It’s the perfect combination.

Interested In partnering with Molecular Testing Labs?

Let us Empower you.