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Medical device design and manufacturing is a complex endeavor right out of the gate. Although you may not realize it when you are getting started, many of the decisions that you make at the concept stage can lead you down the wrong path. You must be aware of all of the potential issues you could encounter if you are to make the correct decision. But how do you do this if you are new to medical devices? You get help. That’s how you do it!
We can help you make those decisions. By understanding where you are going, you can take the straightest path to get there.
Design Controls are key during the design and development phase. They provide you with the path to follow as you proceed through development. Done correctly, they can even provide you with a bridge or two so that some of the obstacles you encounter are easier to deal with.
The reality is that a good design control procedure should be at the core of your business. They help you to know what you are building, how you are going to build it and most importantly, how to PROVE what you’ve built. Without it you can be lost in a very expensive game of chasing your own tail – altering the requirements as you go and repeating the verification work over and over again as the basic requirements change. Without it you will waste a lot of time wandering around aimlessly with poorly defined specifications and will be susceptible to leaving the path entirely via uncontrolled scope creep.
If you have spent any time researching design controls you have probably seen FDA’s guidance document on design control. It is quite illustrative of the process itself. However it can be difficult to understand – particularly if you are not familiar with how design controls are intended to work.
As a new company how do you proceed? You could buy a “canned” system from a 3rd party supplier. However the system you buy will be generic and you will have to alter all of your processes to fit it (even those that are already working well). Or you could contact us. We’ll help you set up a compliant design control process that works within the system you already have in place – improving your system without unduly constraining your creative talent. Trust us, we’ve done it before.
What if you already have a system but you lack the engineering resources for the paperwork required? After all, any form of control requires a certain amount paperwork and we all know how much engineers HATE paperwork. We can help here too. We’re engineers as well so we can talk to your technical staff and extract the information required for the paperwork with a minimum of fuss. Let them concentrate on designing your product. We’ll concentrate on the paperwork.
Setting up commercial manufacturing is not for the feint of heart. The path to commercialization can be a dangerous one that winds between impossible rock faces and steep cliffs.
Beyond the usual technical challenges of finding the correct manufacturing vendors and processes, you have quality control issues to consider. Worse yet, you’ve probably heard about design transfer. This is where you prove that the final process you have developed can manufacture the same product that you tested in your verification and validation steps. There are a lot of pitfalls here and many of them are costly both in time and money.
We’ll help guide you through the process so you can avoid these pitfalls and get your product ready for commercial distribution.
Congratulations! Your device design is complete, you’ve proven that it is what you want and you’ve successfully transferred it to manufacturing. The view from here is breathtaking!
Now you need to submit it to the regulatory agency and get their permission to go to market. If you have done the previous steps correctly then most of the paperwork is already in place. However you still need to dot all the i’s and cross all of the t’s. You may also need to perform additional testing to comply with the regulations in each jurisdiction. You will certainly need to prepare the paperwork to support your submission.
Let us help you. With the help of our associates, we can get the regulatory submission in place for the US, Canada or the EU with a minimum of fuss.