The European Medical Devices Regulation (EUMDR) is a new set of regulations that govern medical devices’ production and distribution in Europe, effective May 26, 2021. The EUMDR requires more stringent clinical evidence for MedTech players than previous guidance (Directive 90/385/EEC, Directive 93/42/EEC). To obtain and renew their Conformitè Europëenne (CE) Mark certifications, many medical device manufacturers will therefore need to collect more evidence proactively via clinical investigations or other real-world data collection activities such as post-market clinical follow-up (PMCF). The key to collecting high-quality data is to rely on excellent guidance and sound technology. Where enough clinical evidence exists, device manufacturers can leverage PMCF Survey options whenever possible as it provides significantly faster results at a significantly lower cost compared to registries and clinical investigations.
Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with EUMDR and other regulations. Our team of experts can help you design and execute your PMCF Surveys! Check out our PMCF Surveys services for more information.
FIND THE RIGHT PMCF SOLUTION FOR YOU
Submitted over 3000+ patient forms to NB in 2022 till date
Our PMCF study costs less than 90% lower than clinical trials
A panel of 4 million pre-qualified & recruited HCP’s
Cetas Healthcare has extensive experience helping European medical device manufacturers with high-quality data capture to comply with EUMDR and other regulations. Our team of experts generates robust clinical evidence for MDR submissions.
Device-specific, MDR-compliant survey protocols
Real-world data collected from empanelled HCPs
Automated data analysis protocols for <5 days turnaround
In-house Ph.D. clinical experts for robust PMCF reporting
SPOC works in conjunction with you to address NB's queries
Our execution model covers four steps
Clinical Objectives - Sample Size Calculation - MDCG 2020-7 Compliant PMCF - Plan and Survey Questionnaire.
Survey Programming - Participant Recruitment - GDPR Compliant Data Collection - Quality Check - Data Delivery.
Statistical Analysis Report - MDCG 2020-8 Compliant PMCF - Report
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Cetas Healthcare is one of the largest, full-service, MedTech-focused Market Research companies in the world. We focus exclusively on the medical devices, diagnostics, and Digital Healthcare marketplace. Our Leadership team brings in over 100+ years of experience from the Medical Device and Market Research industries.
We offer market research, customer insights, and strategy consulting, all aimed solely at helping our clients solve big problems and make critical decisions using insights derived from data and analytics.
We are well-known for our MedTech industry knowledge, our collaborative working style with our clients, and our commitment to go out of our way to deliver value to our clients. It is for these reasons that 13 out of the top 20 global medical device companies trust us for our expertise and we are proud to deliver projects with a 100% client retention rate.