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!
- We can move your devices speedily through the FDA by doing the job right in the first place. Over four decades medical device development, regulatory, FDA and ISO experience speaks volumes for our success rate. We help you design, engineer and document your device correctly, avoiding problems from the outset of your project and saving large amounts of time and money.
- FDA and ISO 10993 biocompatibility, antimicrobial and antisepsis are house specialties of ours, with our having developed from start to finish the world's first and still leading antimicrobial catheter. It was the ONLY antimicrobial device accepted by the FDA for 10 years! Add to these specialties the comprehensive knowledge of the FDA regulatory processes, the development and design of manufacturing processes and comprehensive knowledge of physilogy and biocompatibility and we are the complete medical device service.
- A strong working knowledge of physiology and hospital practices has allowed us to design first rate and readily acceptable medical devices. First rate design and engineering is necessary for a first rate medical outcome. Our device experience has included implantable through external use products.
- A strong knowledge of nursing and physician needs guides our development and consulting services. Understanding how the medical device market works and what is needed to sell into this market arena is a major plus for this firm.
- Why leave your documentation to amateurs, when we have the skills in-house having written SOPs, IFUs, FDA reports, regulatory documentation, process and manufacturing documentation and maintenance documentation. Our experience covers a wide variety of other technical writing efforts across the complete spectrum of both medical and non-medical industrial needs.
- Your company needs cGMP, GLP and FMEA guidance? We have you covered here as well, having incorporated these regulations in our efforts from device design through facility design and audits.
TELEPHONE: 610-916-2949