Whitman Designs has operated across many disciplines and industries and presents an agile, adaptable, and effective method for you to approach engineering problems. With experience in manufacturing process development and improvement, medical device design, rapid data acquisition and analysis, product feasibility evaluation, prototype production, and more, Whitman Designs has the necessary experience, tools, and discipline to approach challenging problems, innovate solutions, and provide you with a winning result that will both succeed and exceed expectations while boosting productivity by freeing up your valuable resources.
Depth and Breadth
While our primary focus is on consumer and medical product development, we understand that there many elements involved in the design process beyond engineering and regulatory documentation. From acquiring and translating VOCs into CTQs and product specifications to developing artwork and writing copy for your IFUs and marketing materials, Whitman Designs will treat all aspects of your project with the same care and attention to detail to ensure both quality and success.
Long-Lasting RelationshipsWe believe strong, long-lasting relationships built on trust and hard work are central to any successful endeavour. Here at Whitman Designs we strive to make every connection we make a meaningful one. Constantly utilizing and cultivating our network allows us to maximize our capabilities and provide you with the best service and results possible. And we hope that at the end of the day we can form a lasting relationship with you as well!
Regulation and Standards
We understand that every industry has its governing regulations and standards. Whitman Designs' primary background is focused on medical device development for deployment in both the NA and EU markets, and as such we are well versed and skilled at operating in highly regulated spaces. Specifically pertaining to medical devices, we are experienced and intimately familiar with:
- Title 21 CFR Chapter 1, Subchapter H - Medical Devices
- ISO 13485, 14971, and 10993
- IEC 62366 and 31010
We also recognize the need for an established and robust quality system as well as documentation at every step - whether it involves DHFs, DMRs, V&V, qualifications, testing protocols, and more.
Navigating the regulatory waters can be difficult, confusing, and treacherous, but we can help you understand the process and requirements so you can launch a winning product, worry free.
There are countless ideas and products in the market, but how many make you stop and say "Wow, I wish I had thought of that!" We're here to make your product one that stands out. By involving our clients intimately in the design process, we often find new approaches and solutions to problems that present a truly novel and elegant opportunity to make something exciting and new.
As the client, you come first. The needs and parameters set by both you and your project will be strictly honoured, be it budget, time constraints, or specific design elements. We aim to be as agile, flexible, and responsive as possible to give you the best experience and end-result possible.