Regulatory Consulting and Clinical Trial Management Services
Companies developing new in vitro diagnostics (IVD) or medical devices are required to perform clinical studies to generate data to support FDA pre-market approval. Companies turn to MDC Associates for our expert guidance in conducting and monitoring clinical studies and obtaining FDA approval.
MDC Associates prepares on average five to ten FDA pre-market submissions per year. We have a perfect track record for submission acceptance for review and we’ve never had a submission rejected for incompleteness.
On average, our FDA 510(k) submission have been cleared within 80-120 days.
In addition to obtaining clearance for professional products, MDC Associates has conducted clinical trials for Over-the-Counter (OTC) products, and successfully submitted several of these for FDA clearance. MDC has also had great success with obtaining CLIA-waivers for IVD products.
With so much at stake with a product launch it makes sense to navigate the rigorous regulatory maze with a company that has successfully done it for over 30 years.
MDC's Regulatory Services
Regulatory strategy and guidance
Pre-submission preparation and FDA meeting support
Clinical and analytical protocols preparation
Clinical trial management
510(k), de novo, PMA FDA submission
CE-marking and Health Canada Medical Device Licensing
Why Choose MDC?
Faster and significantly more cost-effective than hiring own staff or consultants
Consider and support your ultimate end-goal of commercial success, not just regulatory success
30+ years helping both large and small IVD and Device companies achieve regulatory approval
Experience in all areas of IVDs (microbiology, infectious diseseas, clinical chemistry, hematology, high/moderate complexity and CLIA-waiver)
Personalized approach to our clients and manage our schedules and work to your timeline