• Melita Ball

August 4, 2020 Blog Post

Emerging Medical Device Companies An FDA Compliance Roadmap – Part 3

Welcome to Part 3 in this FDA Compliance Roadmap for Emerging Medical Device Companies.  If you missed Parts 1 or 2, you can read them <<HERE>>.

If you followed the guidance for the Idea & Research Phases, you should be well on your way to having what you need in place for successfully getting your product to the market.  The next step is the Development Phase

In this phase, you will put all those plans in motion and get things done.  You will implement the foundational processes for your Quality Management System, fully develop your product, generate records appropriate for the market you want to enter, and submit all the records necessary to finally be able to launch the product. 

Let’s dive into the actionable tasks critical to the Development Phase.

  • Implement Foundational Processes for QMS – At this stage, you certainly don’t have to have a fully developed and implemented Quality Management System; however, you should implement a number of foundational elements for that system to support the operations that you will have shortly.  In a regulated environment, one of the key concepts that you must maintain is a State of Control in everything you do.

A key element of this concept is to control your documents and the changes you make during design and development.  For this, you will need to establish a Document Control

System and a Change Control System. 

Another important element of maintaining a State of Control is that people need to be trained and competent to perform work.  For this, we establish a Training System.

Then, you’ll need to establish a fully compliant Product Development Process that implements your chosen model in a way that incorporates all the requirements for Design Control. 

Last but not least, you will also need to establish procedures and processes to handle your various suppliers and partners that will be used for some of your outsourced processes (including contract manufacturing). Global regulatory requirements stipulate that you must have controls in place to ensure those suppliers are competent to provide the goods and services. 

Let’s take a deeper dive into each of these foundational processes.

  • Document, Record, and Change Controls – All documents and records affecting the product or the quality system need to be approved and version/revision controlled.  Each document has a life-cycle that needs to be maintained and each record provides evidence used to determine if the company followed its processes.  Records are required to be maintained for a period of time depending on the product’s expected life.  Changes to documents or product requirements also need to be controlled in a way that the changes can be traced. All of these requirements start when a company starts developing a product.  These processes are foundational because you really can’t do much work in a regulated environment without them.

  • Training Process – Training and Competence in a regulated environment is not just something we say … we have to prove that the right people are performing the right

jobs.  Implementing an effective training program is a foundational process simply because no one can perform within a regulated environment without first proving that they have been trained and are competent to do the job.  Training needs to be conducted and documented before documents can become effective for the organization. Training needs to be conducted and documented for the design and development team before they can contribute to the design of a new product. Everything we do is affected by how effectively we maintain training.

  • Product Development Process / Design Controls – In the research phase, you decided on what general development model to use.  Now we need to take that general model, add in all the required design control elements and implement it.  The development team needs to be trained on how to use it and what’s required to be documented throughout the development process. 

  • Supplier Controls – Most new medical device companies outsource some of their more critical operations including sterilization, software development, critical custom parts, raw materials, and even the entire manufacturing process.  The accountability and responsibility for these outsourced processes still falls 100% on the owning company.  International regulations require a significant level of oversight of these suppliers including a qualification process to approve them as qualified suppliers, ongoing monitoring of their performance with consequences for non-fulfillment of their obligations, and periodic re-qualification.  Throughout the development process, you will be making decisions on suppliers.  You’ll need to have this process in place early in order to have enough time to properly qualify suppliers.

  • Complete Submission Documentation – Whatever markets you have determined to enter, they will surely have regulatory requirements that must be met before you can

offer your products for sale.  If you thoroughly researched your required pathways, you already know what documentation you need and the general timelines to clearance or approval or certification or licensing.  Now’s the time to execute, gather, organize and submit the required documentation.  Once everything is submitted, there’s a bit of a waiting game before there’s more to do on that front.  But, that doesn’t mean there’s nothing to do!  It’s a great time to qualify any contract manufacturers, create detailed manufacturing instructions, perform process validation, and finish building out your Quality Management System.

Stay tuned for our 4th and final part in this series … The Commercial Phase.

As always, thanks for reading!  Stay safe and be well!

Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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