Packaging Engineering

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It's likely that for you, as in most organizations, packaging engineering is not your core competency.  Your focus is, as it should be, on your customers and your device.  However, the package is a critical component of your product ensuring that the device gets to your customer in ready for seamless, safe, and effective use.  

You could spend a considerable amount of time and money building an internal team.  However that may prove to be a distraction to your organization and you may end up with expensive, underused resources depending on the pace of your projects.  Even if you have internal resources you may come across projects or challenges beyond the capacity or experience level required to adequately address the situation.

At ClearStrat Medical we collectively have many decades of experience in this space and have seen (and solved) just about any challenge that could come up.  We take on your project or provide a resource (backed by our extensive proficiency) to address your need when you need it without the long term resource commitment of hiring a full time employee.

Whether your starting a new company and need to deploy a brand new quality management system or you are updating part or all of an existing one, the process can be daunting.  The notion of writing and reviewing the required procedures to document the systems can be quite daunting.  Additionally the wide ranging a complex array of standards and national regulations can be difficult navigate.

Our focus when it comes to a QMS is to ensure clarity.  The most rigorous procedures can be worse than useless if they are to complex for the organization to use.  A cookie cutter approach might seem efficient but every QMS must be tailored to the organization in order to be useful.

It is not uncommon for label development to be the last step in getting a product ready for deploy either for a clinical trial or for commercial launch.  Yet the complexities of medical device labeling are often underestimated.  Whether it be for the package labels or for the instructions for use the myriad of standards and regulations that must be followed (and sometimes conflict with each other) can be hard to stay on top of in this ever changing regulatory landscape.  Couple that with statistics that show the single largest cause of recall is labeling errors it is enough to stress in even well experienced product development managers.

Bringing in an experienced consultant to manage your labeling project can alleviate concerns and allow the core team to focus on the device and other critical steps necessary to bring your product to market.  Our consultants, backed by the extensive expertise of the broader organization, can help ensure a seamless process and instill confidence in your go to market strategy.