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!
Understanding the regulatory approval process is should never be left to amateurs. We have a vast and highly successful experience with the FDA. We know the regulatory pathways implicitly and this knowledge has led to successes that include shepherding the world's first antimicrobial medical device through the entire process from the initial R&D to all testing and all process development and the formal FDA approval as a 510(K) and not a drug as was the initial FDA position on this new type of device.
Our effort applied specially developed biocompatibility testing to prove the safety and efficacy of an antiseptic coated invasive blood contact medical device. Our testing established the FDA standard for the use of chlorhexidine on invasive medical devices.
Why leave your documentation to amateurs, when we have the skills in-house having written SOPs, IFUs, FDA reports, process and manufacturing documentation Our experience covers a wide variety of other regulatory writing efforts across the complete spectrum of both medical and non-medical industrial needs
TELEPHONE: 610-916-2949
Our effort applied specially developed biocompatibility testing to prove the safety and efficacy of an antiseptic coated invasive blood contact medical device. Our testing established the FDA standard for the use of chlorhexidine on invasive medical devices.
Why leave your documentation to amateurs, when we have the skills in-house having written SOPs, IFUs, FDA reports, process and manufacturing documentation Our experience covers a wide variety of other regulatory writing efforts across the complete spectrum of both medical and non-medical industrial needs
- Full comprehensive knowledge of ISO 10993 testing and the FDA alterations to this protocol
- Comprehensive knowledge in analysis and evaluation of the testing results under FDA and ISO 10993
- Perfomed over 1,500 biocompatibility tests including over a dozen unique tests designed by us to prove safety and efficacy
- Presentations before IRBs for human clinical test approval
- Institutional clinical testing of devices using human patients and animals, including writing CERs (Cliniccal Evaluation Rreport) and IBs (Investigator's Brochure)
- Clinical testing to prove device safety and efficacy using sheep or rabbits or mice or rats or pigs or dogs - clinical tests have been run using all of these species
- Specialists in animal and human clinical testing, including test design and
- Comprehensive knowledge of and experience in all device classifications: Class I, Class II, Class III (also called PMA), Combination Devices, De Novo Devices, Humanitarian Use Device, Humanitarian Device Exemption, Special 510(K) Device Modification
- Capabilities include documentation under GDP (also called GDocP)
- Will set up your entire biocompatibility testing system, complete with documentation, test analyses, FDA submissions
- Worked in consultancy on the device part of two formal NDAs regulated under CDER
- IFUs and labeling for a broad range of medical devices including combo devices and drug delivery systems
- Maintenance instructions for a wide variety of equipment used in device manufacturing and processing
- SOPs for every step of device development and manufacturing from R&D through warehouse storage and release
- Full manuals for production process equipment and processes
- Labeling and IFUs for OTC drug products
- Specifications for design and testing of devices
- Clinical trial design
- Internal documentation
- Record keeping
- cGMP compliance
- FMEA compliance
TELEPHONE: 610-916-2949