Have you met the requirements?

Everyone has experienced a recall one way or another: reading about it in an industry publication, having a product you own taken off the market, or even being the company administering the news. Regardless, a requirement was not met during the product’s development process which has caused the recall to occur.

There are a number of market requirements in place that manufacturers, designers, or developers must consider when designing and manufacturing devices. These can include CE marks, UL registration, IEC or ISO standards, 510(k) approval or even FDA approval. All these exist to ensure that your product is ready to go to market when you are.

Requirements need to be considered early in the process as preparation can take considerable amount of time and effort. The ideal time to begin working on them is when the manufacturing instructions are being developed. This is to ensure that the design is consistent with the product development constraints.

Device History Records are going to help aid in meeting market requirements, so the details of the product should be constantly kept top of mind. “From a product development stand point, defining what is “required” is one of the most important steps, and it will be done, one way or another before the product is finished. The way you do it, and when you do it, will certainly influence the final outcome. My suggestion? Do it early, and be as complete as possible, then revise as necessary. It will streamline your process and save a lot of headache” – Synthesis Engineering Services, Inc.

Finally, a few key items to keep in mind:

  • Where is your product going to be used and/or manufactured? Are there certain requirements you need to meet for that specific country?
  • Do you need to consider HIPPA requirements that ensure your device is safe with patient information should your device utilize cloud-based services? Cybersecurity attacks are putting medical devices at risk of being hacked.
  • Does Medicare reimbursement play a role in the requirements you need to meet?
  • Will your device require FDA classification? Does it have an assigned class already or should you expect a delay if it doesn’t? If it is a Class III this can cause extra documentation and administrative costs which you may need to be prepared for.

Be in the know and consider your market requirements early in the process. Non-compliance can have its own consequences – even recalls.

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