Clinical Operations in the U.S.
– Study Design Strategy, Project Management / Monitoring, Data Management, and Stats Analysis –
4 IVD Projects (18,000 samples)
- DZS was contracted to work on the world’s first fully automated and integrated testing platform for both blood grouping and donor disease screening.
- Goal was to demonstrate on-site rapid results (less than 35 minutes per sample)
- Four part project (2 US/ 2 EU)
- Currently part 1 is being submitted for certification/registration in EU
- Projected submission to FDA late 2018
3 IVD Projects (over 12,000 subjects/samples)
- DZS was contracted to work on company’s first fully automated urine chemistry analyzer / particle imaging device
- Successful approval and launch in US 2017
CRC Diagnostic Study
- DZS has been contracted to design and execute a novel, non-invasive CRC diagnostic tool
12 Additional medical device projects in the last 3 years (respiratory, ICU devices, ophthalmology)
one of DZS Scientific Advisory Board as a Clinical and Regulatory
DZS can guide clients through the regulatory submittal and compliance mazes with our expert who has wealthy experiences as follows
- the Deputy Director within FDA as well providing leadership and input to numerous industry sponsors.
- significant experience preparing and reviewing INDs, NDAs, PMAs, BLA, BLS, and in-vitro diagnostic submissions globally, to name only a few.
- expert in 21 CFR quality systems and FDA 483 examinations.
- With over 30 years of regulatory, clinical, and blood application and medical device application experience.
- currently submitted well over 30 510(k) submissions to the FDA.
Other capability in Medical Device area in Europe and Asia
Clinical Operations / Quality Management / Regulatory affairs / Analytical Services
Our feature of capability is
- We are able to train to new requirements, perform gap-analysis of the Quality Management System and produce technical files against the requirements introduced by new regulations on medical devices and on In Vitro Diagnostic Medical Devices implemented in May 2017.
- We have done consultation and compilation of product technical file for CE-marking or product registration dossiers for several different types of medical devices and IVD products.
- Experience with QMS audits, gap-assessments against requirements and consultation/training on requirements.
- We have vast experience in pharmacovigilance for Medical Devices.
- One ongoing project is to manage and assess cases of health damage and malfunction caused by gastrotomy catheter for treatment of Parkinson’s disease.
Regulatory affairs to get approval in Japan, Malaysia, Australia, etc.
Particularly broad experience and capabilities for Japanese market, PMDA as follows:
- Our clients are based in US, Canada, France, Spain, Switzerland, Germany, Israel, etc.
- For all therapeutic areas, especially cardiovascular, orthopedic, dermatology, ophthalmology.
- Handle medical devices (Class II through Class IV) and IVDs with DMAH (Designated Marketing Authorization Holder) licenses.