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

3. Reporting Structures


Medical Device Complaint Handling Practices

The respondents described various reporting structures with

  • 41% of quality/regulatory/compliance groups reporting to a single point of control and

  • 28% of quality, regulatory and compliance groups having independent reporting structures.


  • There are as many ways to do this as there are companies. The goal is to have a structure that allows effective, efficient and timely oversight and control. The most effective companies I have seen have independent facility RA, QA and Compliance groups with a common corporate oversight group that establishes and maintains consistency. - Ken Imler, Arrow International

  •  I am surprised that so few organizations have a single point of control. I would prefer to see more central control. -Tim Wells, The QualityHub

4. Top Official

There was a wide variation as to the title of the top of official for the quality, regulatory, quality/regulatory and compliance functions. The most common title was vice president or senior vice president.


  • The major issue here is that the top QA, RA and compliance person is at the same level as the top finance, marketing, R&D, etc. executives. - Ken Imber, Arrow International

  • It is important that the quality organization have similar titles as that used in the production or manufacturing organization. These organizations should be viewed as peers. - Denise Dion, EduQuest

  • I concur that this needs to be VP level. In fact Senior VP is appropriate for the larger companies. - Tim Wells, The QualityHub

5. Reporting Relationships

Most of the respondents reported that their quality, regulatory, and compliance officials report directly to the president.


  • Quality, regulatory and compliance are senior management responsibilities and should be recognized as such. - Steve Ojala, Zimmer Corporation

  • In my opinion, companies where quality and compliance functions do not report to the president are often the same companies facing compliance actions by FDA. It is essential that quality report to the CEO/President. This assures independence as well as access to resources. - Tim Wells, QualityHub

6. Reporting to the Board of Directors

A majority of firms (59%) had their senior quality/regulatory/compliance functions periodically report to the Board of Directors.


  • Focused quality companies provide regular updates to the Board of Directors. - Steve Ojala, Zimmer Corporation

  • Since the Board of Directors can also be held responsible for quality system deficiencies, they should be aware through management reviews of quality problems. - Denise Dion, EduQuest

7. Ability to Stop Production and Order a Product Recall

Most respondents (91%) reported that their firms allow their top quality/regulatory personnel to stop production or order a recall.


  • All world-class quality companies empower the quality and regulatory functions to stop production or initiate a recall. - Steve Ojala, Zimmer Corporation

  • This is a positive trend that should be reinforced. - Denise Dion, EduQuest

8. Scope of the Regulatory Function

A majority of firms (67%) reported that the regulatory function was responsible for product submissions, compliance to QSR, and ISO13485; while 37% reported that the regulatory function was only responsible for product registrations and licenses.


  • Depending on the size and structure of the organization, this can be combined or separated. In either case, the functions must communicate and coordinate their activities. - Ken Imber, Arrow International

  • Regulatory and quality are almost inseparable functions that need to be tightly coordinated to be effective. - Steve Ojala, Zimmer Corporation

  • I am seeing more and more separation of the quality and regulatory functions. Unless the company is quite small, I would not recommend combining responsibilities. It spreads the manager too thin. - Tim Wells, The QualityHub




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