• Melita Ball

August 11, 2020 Blog Post

Emerging Medical Device Companies

An FDA Compliance Roadmap – Part 4

Welcome to the 4th and final part in this FDA Compliance Roadmap for Emerging Medical Device Companies.  If you missed the first three parts, you can read them <<HERE>>. In part 3 of this series, we stopped with the delivering of the submission documentation to the regulatory authorities.  There may be some back and forth during the process as regulators review the submission but once that is done to their satisfaction, you will finally get the clearance or approval to put your device on the market.  You will now enter what we call the Commercial Phase. In this phase, there are lots of things to do.  First and foremost, you need to complete building out all the required elements of your quality management system, officially qualify your suppliers, implement all the manufacturing specs, scale up from development to production, ensure that you have quality oversight built into your processes, and maintain your system. Let’s dive into the actionable tasks that must be accomplished before you can ship your first product.

  • Implement the rest of the QMS – In the Development stage, you implemented the foundational processes necessary to develop your product but there are many more requirements that need to be built into the QMS before it is considered compliant and in a State of Control.  Remember, all of your processes need to be in place and validated, where necessary, before you can ship product to end customers.  Here they are:

  • Management Responsibility – Executive Management is ultimately responsible for the safety of the product and for ensuring that the quality system is established,

maintained, and compliant.  Executive Management consists of the CEO or President and those senior executives that report the her/him.  Executive Management is required to review the effectiveness of the quality system and the status of the product in the field at regular intervals.  They are also responsible for ensuring that there are enough qualified people to manage the QMS and that the organization is structured in a way that eliminates conflicts of interest and provides the appropriate authority to act.  The executive team is also held accountable to ensure the training system is adequately maintained and that personnel are trained to perform their responsibilities.  Another important responsibility is to ensure that the organization is executing internal quality audits according to a documented schedule.  “Management Responsibility” is very vulnerable for small, emerging companies simply because they neglect to connect these senior executives to real responsibilities within the day-to-day quality management system.  Remember, these are not optional and are required by the regulations and standards governing this industry.

  • Corrective & Preventive Action (CAPA) – Many people think that CAPA is one singular process.  The truth is that it is a group of processes that are all focused on one thing … monitoring the performance of products in the field and monitoring the health of the QMS.  This area is also where the organization will take specific actions when things don’t go the way they should.  Some issues that fall under the

“CAPA” area are things like analysis of data and metrics, feedback, complaint handling, reporting of adverse events to regulatory authorities, non- conforming product, rework, failure investigations, recalls & advisory notices, and, of course, corrective actions and preventive actions.  Each of these areas are different from a process point of view so we have to create processes for each.

  • Facility & Equipment Controls – If you are manufacturing your own product, you need to spend some time thinking about and implementing proper facility controls that are appropriate for your product.  Usually, renting office space in a strip mall doesn’t work well for manufacturing medical devices. You have to ask … Is the building designed so that product flows through it in a logical way that prevents pieces and parts from being mixed up? Have pest control measures been implemented? Is your product temperature or humidity sensitive? Will your product be sterilized?  Are there contamination concerns?  Is your product manufactured using equipment that needs to be qualified and maintained?  Are your product sensitive to electrostatic discharge?  The answers to these questions will drive how much or how little you need to put in place.  If you are using a contract manufacture, remember that you are still 100% responsible to ensure that your product is being manufactured in a facility that is compliant with these requirements.

  • Production & Process Controls – If you are manufacturing your own product, you need to translate the design and all the product specifications into manufacturing instructions.  You’ll also need to implement acceptance criteria for anything that could cause the product to fail in the field and implement inspection and testing points to ensure the product meets these criteria before shipping to customers.  Any automated processes also need to be validated if you cannot fully verify the output.  Again, if you are using a contract manufacturer, you are 100% responsible for everything they do so you need to qualify, monitor, and manage them.

  • Material Controls – This group of procedures and processes is all about how you handle, store, distribute, install (if required), and service (if required) not only

your finished device but also any raw materials, components, and sub-assemblies that you purchase from others.  These processes ensure that materials and products are not damaged and are properly installed and serviced prior to use.  They also ensure that things are organized to prevent mixing-up materials and everything is identified and can be traced.  Distribution records are extremely important if you ever have to recall the product from the field due to a problem.

If you follow the advice in this four-part series, you will find that getting your product on the market with a compliant and well-defined Quality Management System is less stressful than you might think.  As a final thought, its important that a knowledgeable quality and regulatory compliance professional is involved in the creation of your QMS.  Whether you hire them into the company or outsource be sure they are qualified to do the work; otherwise, you may end up spending more money and time fixing their mistakes. I hope you enjoyed this series! Do you have a topic idea that you would like to suggest? Enter it <<HERE>>. As always, thanks for reading!  Stay safe and be well!

Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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