As a new medical device start up, the process of making your product compliant might seem daunting, but it doesn’t have to be. The experts in the field have some solid advice for getting on the right path.
“A key piece of advice would be to have a strong regulatory strategy from the beginning as part of your business plan. In our expertise, we’ve found that regulatory strategy plays a vital role in the success of a start up,” says Scott Wright, founder and CEO of A Wright Path, Inc., a regulatory consulting firm specializing in medical device start-ups. “We suggest building your quality management system during the development stage. It is helpful to have someone with quality system experience to guide you through the process.”
The consulting team at A Wright Path created a list of things for start ups to plan for during the process to ensure compliancy success:
- Implement a thorough Quality Management System as the foundation for your business success.
- Document your medical device requirements early to ensure design controls are followed.
- Establish your Regulatory Strategy for your medical device, identifying the markets you choose to distribute your device to.
- Create a Risk Management File to ensure that risk management activities are included through every phase of design and development, including identification of potential hazards which may arise with your device and the likelihood of any harm. Your Risk Management File is a living document that is reviewed and updated through your development process.
- Gain approval of all your suppliers and maintain appropriate controls over these suppliers throughout manufacturing. Maintain
- Establish a document storage system that works for your company and maintain document and record controls.
By building your start up and medical device in a responsible way, you’ll already be generating the necessary documents which are key to compliance. Having experts on your side during these initial start up phases will ensure compliance from the beginning. Then you can deliver an airtight submission package to the FDA.
“We also advise that you be selective in who your consult with during the process. Many consultants in the field specialize in large medical device companies. Be sure to find someone who will partner with you throughout the entire life cycle of your device and ideally, they should have startup expertise,” recommends Principal Compliance Specialist Deb Gimbel. “It’s a good idea to listen to those who have vast industry experience who will be able to guide you along the right path.”
Founder Scott Wright adds, “The FDA wants you to succeed. And so do we.”