• Melita Ball

April 28, 2020 Blog Post

(Re) Designing a Quality Management System:

The Right Reasons Explained

This new blog series is specific for those of you in the Medical Device sector.  I’ve had a number of people reach out and ask specifically about designing and building a Quality Management System so I thought this would be a good time to put a series together related to that alone.

Don’t stop reading if you belong to a large Medical Device company or if you currently consider your Quality Management System established.  The truth of the matter is that there are a number of factors that can cause a company to have to design or re-design their Quality Management System (QMS) without a lot of notice.  This blog series will help you prepare for that moment and avoid some common pitfalls that will result in predictable and unpleasant outcomes.

So, what are some reasons that companies are designing or re-designing their Quality Management System or their QMS?

  • A new company seeking to market their product for the first time

  • A merger or acquisition

  • Consolidation of business units under one QMS

  • The issuance of a significant Warning Letter

  • The ruling of a Consent Decree

  • Turnover of Executive Leadership for the company

  • Internal Audits and Management Reviews determining that the QMS is not effective

  • Business drivers to become more efficient and lean

  • Business drivers to consolidate and upgrade older, complex legacy software systems supporting the QMS to more efficient, reliable, and modern technologies

  • Significant changes to regulations and standards that affect the Quality Management System

All of these are good reasons! 

Let’s take a deeper dive into the first one on the list today as this one is likely the most obvious but also needs a little more explanation. 

A New Company Marketing Their First Product:

If this is you and your company has developed the next ground-breaking disruptive technology that will change the course of medicine for the better, then let’s make sure that technology sees the light of day. 

Many start-ups out there call me or send an email asking for my help and they only have one thing on their mind …

They want to talk about their regulatory pathway for getting their product cleared or approved by the FDA or want to talk about getting their product’s CE Mark to enter the EU market. 

Don’t get me wrong … Clearances, Approvals, and CE Marking are all definitely on the critical path to the market but I am still astonished by the fact that almost no one has thought of or, more importantly, planned for the far more expensive barrier to market entry … the establishment of an effective Quality Management System (QMS).

The FDA’s website states the following:

“The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

  • Establishment registration,

  • Medical Device Listing,

  • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),

  • Investigational Device Exemption (IDE) for clinical studies

  • Quality System (QS) regulation,

  • Labeling requirements, and

  • Medical Device Reporting (MDR)”

The last three requirements in the list are all associated with the development of an effective Quality Management System (QMS).  Additionally, any company seeking a Premarket Notification or a Premarket Approval must certify in writing that they have established a Quality Management System prior to submission; including all the requirements and documented evidence associated withDesign Controlsspecified in the Quality System Regulation.  There are also additional regulatory requirements associated with the QMS that are not listed here like 21 CFR Part 11 if you plan to utilize computer systems to manage the QMS or the manufacturing process and the establishment of processes and procedures for Corrections and Removals (Recalls).

In Europe, the current MDD and the upcoming euMDR and euIVDR also require a QMS and, on top of that, European medical buyers (as well as other countries) will only buy medical supplies from companies that hold ISO 13485:2016 certificates.  ISO 13485:2016 is the European Union’s (EU) equivalent to the FDA’s Quality System Regulation and the two are well aligned after the most recent update to the ISO Standard in 2016.  Thanks to COVID-19, companies now have until May 2021 to comply with the new euMDR but the deadline for the new euIVDR remains unchanged at 2022.

There are significant regulatory, legal, and financial consequences for going to market with a product without a QMS.  There are a couple of scenarios where this is possible. 

First, for some very low risk devices in the US, there are no submission requirements to the FDA.  The company still must register and list with the FDA and the FDA can and will inspect their manufacturing facilities and their QMS.  If they find that no QMS exists or if the QMS is not effective, a Warning Letter or worse will invariably be forthcoming.  There are costly penalties associated with regulatory actions taken and the company still must correct all the deficiencies to the satisfaction of the FDA before the FDA closes the action against them.

Second, for devices requiring Premarket Notification or clearance to market, it is possible to get clearance for a device without having established a QMS.  This is because the FDA only asks the submitter to certify that they have an established QMS.  They don’t actually inspect them to ensure that it exists prior to granting clearance.  They use their surveillance authority to inspect the manufacturer and their respective QMS at some point after clearance is granted.  It is important to note; however, when they come to inspect, they will be asking for documentation and evidence that the QMS was established at the time clearance was granted.  If they find otherwise, costly penalties accrue while the company either corrects the deficiencies or runs out of money.  This scenario, unfortunately, is all too often the reality.

One last note on the establishment of the QMS … it is the responsibility of the company registered with the FDA and/or the company that is granted clearance or approval to establish and maintain the Quality Management System even if they outsource the actual manufacturing of the device to a 3rdparty.

If you have a new medical device company and have not planned or budgeted for the establishment and maintenance of your Quality Management System, it won’t matter how novel or innovative or ground-breaking your technology is.  Sooner or later, you will end up either out of business or constrained to developing your QMS under the duress of legal regulatory action and long-lasting scrutiny by the FDA.

It doesn’t have to be that way.  The Quality Management System is your single most important investment to ensure that not only your products make it to market but also assures they will stay there for years to come. 

Additionally, as you will learn in a later post, companies that understand the intent of the regulations from the outset will be better equipped to get this right and with all the efficiencies built in to succeed in this highly regulated environment. In my next post, I’ll explore the rest of the reasons listed above for re-designing your QMS.  Then, we will move directly into how to make sure you are successful doing it! As always, thanks for reading!  Stay safe and well! Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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