Medical device and diagnostics research is a broad and increasingly complex area. Our experienced and specialized team ensures that studies on your products generate evidence to help them gain approval. We have a dedicated business group focusing solely in this area whose knowledge can guide you from concept to market.
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20+
years' average length of experience among our leadership team members
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400+
studies performed in medical device and diagnostics
Understanding the Unique Regulatory Landscape in Medical Device and Diagnostics
In the process of bringing products from concept to market, there are requirements that are unique to medical device and diagnostics. Unlike drug development, your product is an “invention” that can be refined if there is evidence to support design modifications. We have performed more than 400 studies in this area, with emphasis on user feedback, to optimize your product.
We Have the Experience You Need to Successfully Execute Your Medical Device and Diagnostics Trial
Our team has extensive experience across Cardiac/Vascular, Aesthetics, Orthopedics, IVD and general device/surgery and we have successfully supported trials in Asia Pacific, Europe and the U.S. Our team understands the nuances and needs of your trial and can guide you through study design, regulatory pathways, site management and study execution challenges.
Everyone on the team is CFR, GCP and ISO-14155 trained to ensure your program is compliant anywhere in the world. We also have the experience to know how best to budget and operationalize your study, whatever the phase. We understand the requirements and different needs of an FIM/feasibility, pivotal or post-market study.
Regulatory Consulting
Our experience covers 510(k), including predicate device evaluation and submission dossier; IDE preparation, including pre-IDE meetings, PMA preparation and submission; CE mark; and medical device and diagnostics classification determination.
Study Expertise
Our expertise includes the following types of study: Combination device-drug delivery products; Health economics and Reimbursement; FIM and Feasibility; Human factor; IVD and Companion Diagnostics; Post-approval and specialized statistical models; and combination products.
We Work With Sites and Investigators to Get the Best Outcome for Your Product
We were voted “Top CRO to Work With” among top 10 global CROs in the 2017 CenterWatch Global Investigative Site Relationship Survey.
These accolades reflect our dedication and ability to collaborate effectively with global customers and sites in the development of new treatments to improve patient lives. Many of our CRAs and Project Managers are dedicated to specific sites and investigators, and have worked closely with them for over a decade, so they know the most suitable sites and investigators to achieve the best outcomes for your product.
Our Proprietary Trusted Process® Helps Ensure the Quality of Your Medical Device and Diagnostic Studies
Our Trusted Process is flexible and scalable to adapt to any sized company or study. It is the project management methodology we use that is proven to deliver dependable outcomes and actionable results, both on time and on budget. We have the knowledge and strategies required to successfully develop your medical device.
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