Device Designs FDA is a full service medical device
consulting company. Why go to several companies
when Device Designs FDA can do your job under
one roof!
OUR MOTTO: Time is money. Even a small delay in a product
release can cost thousands of dollars from lost sales, lost marketing
edge, frustrated customers! We are committed to saving your valuable
time, maximizing the use of your resources, helping you win!
consulting company. Why go to several companies
when Device Designs FDA can do your job under
one roof!
OUR MOTTO: Time is money. Even a small delay in a product
release can cost thousands of dollars from lost sales, lost marketing
edge, frustrated customers! We are committed to saving your valuable
time, maximizing the use of your resources, helping you win!
Engineering design and application should not be done in a vacuum. Successful device designs must account for the needs of both the medical practitioners and the patients.
Our approach can save your company significant time and money by fully understanding patient physiology, disease etiology, health care workers' time and space constraints, the cost justifications that directors and buying personnel must make. As a device progresses from initial design to manufacturing all of these considerations must constantly be taken into account.
Moreover, as a device progresses from the initial design through the laboratory and, where required, animal clinical testing through process and manufacturing design and into the regulatory process we keep totally abreast of the requirements under FMEA, biocompatibility and cGMPs. Nothing can be left to chance in medical device design and release to the marketplace.
We have a broad experience understanding how patients interact with their devices and what rigors the device has endure. Patients are in a compromised physical and, often, mental state and are known to destroy or remove devices attached to their bodies. Understanding what patients can do to their devices and how the device must perform are paramount to successful device engineering.
TELEPHONE: 610-916-2949
Our approach can save your company significant time and money by fully understanding patient physiology, disease etiology, health care workers' time and space constraints, the cost justifications that directors and buying personnel must make. As a device progresses from initial design to manufacturing all of these considerations must constantly be taken into account.
Moreover, as a device progresses from the initial design through the laboratory and, where required, animal clinical testing through process and manufacturing design and into the regulatory process we keep totally abreast of the requirements under FMEA, biocompatibility and cGMPs. Nothing can be left to chance in medical device design and release to the marketplace.
We have a broad experience understanding how patients interact with their devices and what rigors the device has endure. Patients are in a compromised physical and, often, mental state and are known to destroy or remove devices attached to their bodies. Understanding what patients can do to their devices and how the device must perform are paramount to successful device engineering.
- Bring a device from concept to finish
- Improve a current design at any point during the project
- Design for sterilization that is efficient and meets regulatory standards - often a design flaw in the development of sterile devices
- Select the appropriate materials of construction
- Applying a comprehensive knowledge of materials and their interactions with various sterilization processes
- Design to improve patient safety and comfort while enhancing and simplifying the work of health care practitioners
- Critique your design; we will be straightforward and honest and not hold back on any problems we encounter
- Improve device surfaces for increased biocompatibility through coatings and other surface treatments
- Establish device specifications and performance standards
- Help bring the device into the manufacturing and marketing phases
- Hydrophilic (slippery) and hydrophobic coatings on a broad range of materials from plastics to metals are a unique specialty of ours
- Build ultra-high purity water systems that deliver water for device cleaning and treatment that is pyrogen-free with quality less than half that of water for injection. We have developed a half dozen major high purity water treatment systems
TELEPHONE: 610-916-2949