The Structure of Medical Device Firms' Quality/Regulatory/Compliance
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
I believe that an ideal organization should have the following structure:
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.
The top officials for
quality, regulatory and compliance should be at the vice president level,
equal in seniority to other officials in staff positions.
The top quality and
compliance officials should report to the president and periodically address
the board of directors.
All firms need to
measure the cost of poor quality and invest sufficient resources in
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:
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).
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
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
Nancy's email address is