Bigger is not always better … especially for your infrastructure systems.
When considering 510(k) needs or ISO 13485 content, the natural inclination is to include as much material as possible. A 90-page manual is better than a three-page manual, right?
Extraneous facts and verbiage will work against medical device regulatory submissions. Standard operating procedure will get you bogged down in details about what people already know.
The smart approach is “lean and mean.” Focus on practical applications. Think through the implications. You want a quality system that is easy to implement and easy to change.
Why? Change in the medical device market is inevitable. New options pop up. People come and go. Your system needs to roll with those changes, whatever they are.
SpectraMedEx will streamline your existing infrastructure, or start from scratch to create a custom program that gets your company moving. We incorporate vital business elements into your plan, too, such as tax considerations, liability risks, and employee efficiency.
Our comprehensive approach includes cross-training employees for other notified bodies such as OSHA and HIPAA. The regulatory world exists outside of FDA and ISO. Your company’s employees should know this, and be ready.
Smart infrastructure takes real-world costs and the risk of dispositions into account. Built-in flexibility saves filing fees for repeat submissions.
This doesn’t mean more documentation, just better documentation. With SpectraMedEx, your infrastructure won’t be based on volume, but on quality.