Neglecting Regulations and Quality System Requirements is Detrimental to your Business

Mark E. Ramser, VP Quality Management, MedSurgPI, LLC; Peter C. Johnson, MD, Principal, MedSurgPI, LLC; Gerald L. Klein, MD, Principal, MedSurgPI, LLC

It’s never too early to start designing and implementing a company’s quality management system (QMS). Initiating the R&D process is not a problem for companies that have a well-defined QMS and a mature understanding of how it should operate. However, without a well-defined, compliant and effective system, this could be the start of potential future quality and regulatory nightmares. Even with a well-defined system in place, significant problems can occur if the organization is lacking the maturity and experience to utilize it properly. Typically, the R&D function is where most people think a product starts. The founders may not have any understanding of regulatory or quality system requirements. They can simply be focused on developing and launching a product, choosing to worry about the regulatory and quality system requirements once they have a product to sell. Unfortunately, by waiting until the product is ready for market, it will be too late. The ISO 13485 standard, 21 CFR Part 820 (FDA Regulations) and MDR (European Medical Device Regulations) require and expect the product development and launch to be performed under controlled processes and systems. Refer to the following links for the above referenced standards and regulations:

  • ISO 13485 (Quality Management System for Medical Devices)

  • 21 CFR Part 820 (FDA Medical Device Regulations)

  • MDR (European Medical Device Regulation)

The notified bodies and regulators expect the following areas to be controlled and managed per their documented standards and regulations:

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The most critical in early stage product development are:

  • Documented Quality Management System

  • Design Controls (Design History File sub-bullets to prove all these areas are addressed)

    • Design and Development Planning

    • Design Inputs

    • Design Outputs

    • Design Reviews

    • Design Verification and Validation

  • Change Management (design, system, process, supplier, raw material, etc.)

  • Process and Production Control

    • Process

    • Equipment

    • Supplier Selection and Control

Many of these activities need to be initiated from the start of the R&D process and the establishment of a Quality Policy and Quality Process at the proper time falls squarely upon the CEO. Companies cannot generally recreate documentation history at later dates in preparation for an FDA or regulatory body audit. The company is then open to all the risks related to not having required systems during product development. The risks can vary based on the severity of the issue and can range from:

  • A Form 483 may be issued to the firm. Form 483 is the communications method used by the FDA to inform the company’s management of objectionable conditions. This should be followed up with a thorough investigation, root cause analysis and corrective action within 15 days. These are available to the public, but only when specifically requested.

  • Severe issues on Form 483 or a significant number of issues on Form 483 could result in the issuance of a Warning Letter. A Warning Letter is one of the FDA’s principal means of achieving prompt voluntary compliance with the Act. The warning letters are much more significant than a Form 483 and are publicly posted on the FDA website and are easily searchable. This must be followed up with a thorough investigation, root cause analysis and corrective action within 15 days.

  • Additional actions can result in a consent decree, product seizure and up to and including criminal prosecution against the firm and individuals, with a special focus on the CEO.  A consent decree may be viewed as the equivalent to a court order under which the manufacturing and distribution of products can only resume, with conditions closely monitored by FDA.

The regulations defined in 21 CFR Part 820 are legal requirements and carry the stiff penalties noted above. This carries much more significance than merely an ISO standard that defines the requirements without having any legal recourse. One must keep this in mind from the earliest possible point of the inception of the company and not just during the product launch. Not following QMS at product inception and all along the development cycle can have dire consequences for the company.

The timing of onset and the complexity of any company’s QMS is dependent upon the risk that a product may represent when used with humans. Therefore, judgment and expertise are required to properly craft and institute such systems. MedSurgPI can assist your company at the earliest stages to institute a QMS, perform Gap Assessment and Corrective Actions for an existing QMS and assist with the ongoing management of a QMS. Please contact for additional information.