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

July 2006


Medical Device Complaint Handling Practices

                    A Compliance-Alliance survey 



Two hundred and fifty eight (258) professionals in medical device firms completed the survey. Respondents represented firms of various sizes that manufacture medical devices in class I, II and III. With the exception of the number of personnel employed in specific functions, there were no significant differences among the answers based on the size of the firm. For a breakdown of the number of personnel employed in various functions, see Appendix 1.

1. Organization of Quality/Regulatory/Compliance Function

Approximately half of the firms organized their quality/regulatory/compliance function locally by manufacturing site, while the other half had corporate oversight for these functions.


  • Corporate must have oversight responsibilities and direct responsibility for QA and RA. Corporate is the umbrella over all other systems and facilities. - Ken Imler, Arrow International

  • In large firms, any given manufacturing site quality system should have a definite mechanism for assuring the site complies with corporate quality policies. FDA will hold headquarters management accountable/responsible for site failures. Corporate management reviews should include assessments of site quality functions. - Denise Dion, EduQuest

2. Responsibilities

There was variation among the responses about who was the responsible party for each function. The most common responses indicate that

  • Quality has responsibility for CAPA management, document control, equipment calibration, external audits, final inspection, incoming inspection of raw material, in process inspection, internal quality audits, management representative, product and GMP audits, product complaint management, product releases, process validation, risk management, sterilization, supplier program management, and supplier qualification.

  • Regulatory has responsibility for adverse event reporting, annual product releases, facility registration and licenses, production registration and certification, product regulatory submissions, and recalls.

  • Compliance/other groups have responsibility for business code of conduct, environmental program management, health and safety program management, preventive maintenance, and training.


  • In addition to the items others have listed, my experience has been that the most effective QA and RA groups have a major role in establishing, maintaining and continuously improving metrics, monitoring and reporting of quality data. The key areas are NCMR, CAPA, complaints/MDR/field actions, change management, risk management, and management responsibility. This does not exclude other areas; these are the primary areas. - Ken Imber, Arrow International

  • Having separate functions for quality, regulatory and compliance is normal. The management representative should have a mechanism to be informed of all quality issues, no matter what department he/she is part of. It is also important to assure quality remains independent of production (or R&D in design only) facilities. - Denise Dion, EduQuest




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