Do I Need a Medical Device Consultant to Review My Quality Management System (QMS) and/or Help with My 510(k) Submission?

QMS Risk Management

What is a Quality Management System (QMS)?

As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It doesn’t take more than one FDA inspection to figure this one out. If you are involved in, or considering entry into the medical device industry and have not experienced an FDA inspection, a review of FDA’s Quality System Regulation CFR-Code of Federal Regulations Title 21, Part 820 – Quality System Regulation is a good idea. What is a QMS? “…a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis”.[1]

Importance of your QMS

It is not uncommon for first time 510(k) developers to overlook the importance of the QMS. First, hiring a contract manufacturer does not excuse responsibility for a compliant QMS. Second, no reputable consultant is going to prepare and submit a 510(k) for you without an understanding of the condition of your QMS, because third, registering your facility and listing your product establishes you as a target for inspection. Whether you manufacture medical devices or plan to contract out the manufacturing, it is best to operate as if you will be inspected in the near term.

When you hire a medical device consultant for compilation of a 510(k), be prepared to furnish a quality manual, other summary of the QMS, or at least a list of SOPs. You should also be prepared to provide copies of the design history file (DHF) and device master record (DMR) (see Table 1 for excerpts of the relevant regulations). Your consultant should be able to help you implement or upgrade your QMS as applicable. In order to facilitate Contract Manufacturing Organization (CMO) compliance, it is also best to involve your device consultant in CMO sourcing as part of the 510(k) compilation. If you are or plan to manufacture your medical device, select a consulting firm such as PDG® with quality engineers and former FDA inspectors on the team.

Table 1

Section 820.30 Design controls
(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
Sec. 820.181 Device master record
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.

Do you have everything necessary for your 510(k) submission?

Put simply, a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent), to an already legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA (Premarket Authorization-most class III devices).[2] There are various types of 510(k) submissions, but for the sake of this article, we assume the traditional submission.

With all of the above in mind, do you believe your organization has everything on hand to submit a 510(k) to the FDA for your class II medical device? As noted above, the QMS is a prerequisite to a 510(k) submission in that production of your medical device and FDA inspection readiness relies upon it. However, it is not the only documentation needed to prepare for your 510(k). There are various additional requirements for your 510(k) submission packet. If you are not familiar with those requirements, or you have concerns related to your QMS or CMO, it may be time to enlist a medical device consultant.

Which outputs of the QMS are necessary for 510(k) preparation?

It is important to note that most class I medical devices are exempt from premarket notification and quality system requirements. On the other hand, 510(k) submissions and compliant QMSs are required for most class II medical device products (Class III devices require a PMA, a Pre-Market Authorization). If you are not sure of the classification of your device, your medical device consultant should be able to help you make the determination. While outputs of your QMS will provide a portion of the information needed for preparation of the 510(k), i.e. manufacturing information, proposed labeling and a device description (in your DMR), there are also a myriad of additional forms and significant research requirements to prepare a 510(k) submission. Gone are the days of turning in minimal forms and your 510(k) user fee. Recall that in 2010 many believed the era of the 510(k) might be coming to an end. By 2013, FDA was refusing to accept 60% of 510(k) submissions, but the program survived and in 2015 FDA issued a report noting that “Over the past five years, the Food and Drug Administration’s device program has shown a pattern of markedly improved performance.”[3]

Today’s FDA guideline for a traditional 510(k) suggests 21 sections be included in each submission, at minimum (see Table 2).[4], [5]

Table 2

  1. Medical Device User Fee Cover Sheet (Form FDA 3601)
  2. CDRH Premarket Review Submission Cover Sheet
  3. 510(k) Cover Letter
  4. Indications for Use Statement
  5. 510(k) Summary or 510(k) Statement
  6. Truthful and Accuracy Statement
  7. Class III Summary and Certification
  8. Financial Certification or Disclosure Statement
  9. Declarations of Conformity and Summary Reports
  10. Executive Summary
  11. Device Description
  12. Substantial Equivalence Discussion
  13. Proposed Labeling
  14. Sterilization and Shelf Life
  15. Biocompatibility
  16. Software
  17. Electromagnetic Compatibility and Electrical Safety
  18. Performance Testing – Bench
  19. Performance Testing – Animal
  20. Performance Testing – Clinical
  21. Other

QMS is overarching to your facility, a 510(k) is product specific

As you become familiar with QMS and 510(k) requirements, you will note that most of the 21 suggested items in the 510(k) device submission are specific forms and documents for each product, that are not always readily available in your overarching QMS, i.e., CAPAs (Corrective and Preventive Actions) and DHRs (Device History Records). New forms and sections are created for each 510(k) submission, and you will have to conduct specific research to ascertain which “cleared” predicated devices on the market are substantially equivalent to the specific product you anticipate marketing. FDA may require you to conduct testing on your product to ensure it is safe and effective prior to marketing. As medical device consultants, we find these and QMS upgrades to be frequent points at which we are asked to assist with medical device regulatory submissions.

Other benefits of a QMS

If you haven’t implemented a QMS at your facility, there are other benefits to your overall organization. Here are two benefits cited from ASQ (American Society for Quality)[6]:

  1. Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business.
  2. Meeting the organization’s requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit.

Within these overarching benefits are advantages like helping to communicate a readiness to produce consistent results, preventing mistakes, reducing costs, ensuring that processes are defined and controlled, and continually improving the organization’s offerings.

Need assistance with your QMS and/or 510(k) submission?

Having a solid quality management system in place is a great foundation and good indicator to FDA that you understand the importance of quality and that your submissions may be relied upon to have consistent integrity. If you have never submitted a 510(k), or you are experienced but have misgivings about the state of your QSM, potential for testing requirements, selection of a predicate device or sourcing of a CMO, consider engaging the medical device consulting services of PDG’s highly qualified team. This is especially critical, if you have a deadline to get your medical device to market, you wish to ensure a smooth and efficient process, you are facing unfamiliar new requirements or you do not have seasoned QA/RA employees on staff to devote the resources to completing the application.

Your medical device consultant should also function as your regulatory strategist and help you decide up front if a 510(k) is applicable, if so, what type and are their potentially more efficient ways to get your medical device to market. See PDG’s previous articles on FDA’s pre-sub program and FDA’s third party review program. Above all, if you need help with your 510(k) submission or with your Quality Management System, contact PDG today for all of your consultancy needs. We have experts on staff in the fields of Quality Implementation, Quality Auditing as well as Regulatory, for your product registrations.

Jodi Hutchins is an Independent Regulatory and Quality Consultant with over 15 years of global medical device registration experience, to include FDA 510(k) submissions. She held her most recent position for 9 years, as QA/RA Director for a Worldwide distributor of medical devices.

Charles Jaap is Vice-President of Operations and Business Development for PDG, a global pharmaceutical and medical device consultant with extensive experience in the strategic development of drug products and medical devices. Please feel free to contact us for more information.

[1] What Is a Quality Management System (QMS)? — ISO 9001 & Other Quality Management Systems. As accessed at on September 21, 2016.
[2] Premarket Notification 510(k). As accessed at on September 21, 2016.
[3] Florida Based Medical Device Consultant on 510(k) Submissions. As accessed at on September 21, 2016.
[4] Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s. As accessed at on September 21, 2016.
[5] CFR- Code of Federal Regulations Title 21 Sec. 807.92 Content and format of a 510(k) summary. As accessed at on September 21, 2016.
[6] Ibid @ 1