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Survey Results on The Structure of Medical Device Firms' Quality/Regulatory/Compliance Functions

July 2006

A Compliance-Alliance survey 


Nancy Singer



Throughout my career (as a prosecutor, educator, lawyer in private practice, and trade association advocate), I have met many professionals in the health care industry. They have told me that they would like a mechanism to benchmark best practices for building a quality organization.

My company, Compliance-Alliance, collaborates with knowledgeable experts to create surveys on how companies are setting up their procedures for regulatory compliance. We ask professionals in device and drug firms to complete the surveys, and then we disseminate the results.

My goal is that people will use the data to convince their management to provide them with the necessary support to construct quality organizations that produce safe and effective health care products.

The purpose of this survey on the "The Structure of Medical Device Firms'

Quality/Regulatory/Compliance Functions" was to find out about the internal organization of medical device firms. The results indicate that although many professionals have the resources and authority to do their jobs, some do not.

I believe that an ideal organization should have the following structure:

  1. If the firm has many divisions and a corporate headquarters, the corporate staff should have oversight of the regulatory compliance activities of the divisions. FDA will hold all of the divisions accountable for fixing discrepancies found at any location. Corporate staff needs the authority to institute corrective and preventive actions throughout the company.

  2. The top officials for quality, regulatory and compliance should be at the vice president level, equal in seniority to other officials in staff positions.

  3. The top quality and compliance officials should report to the president and periodically address the board of directors.

  4. All firms need to measure the cost of poor quality and invest sufficient resources in preventive action.

  5. Firms need to embrace risk management and utilize its concepts throughout their quality, regulatory, and decision-making processes.

The next seven pages contain the survey results. I have summarized the data and asked the following people to provide comments:

  • Denise Dion, Regulatory Consultant, EduQuest, (formerly with FDA),

  • Ken Imler, Senior Vice President for RA/QA, Arrow International,

  • Steve Ojala, Vice President RA/QA Zimmer, and

  • Tim Wells, President of The QualityHub, Inc. (formerly with CDRH).


Medical Device Complaint Handling Practices




Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process.


She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. For her efforts, she received Vice President Gore's Reinventing Government Hammer Award and the FDA Commissioner's Special Citation Award.
Nancy's email address is

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