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Best Practice Database
Quality, Compliance and Regulatory » Regulatory Affairs
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The European Union Medical Device Regulation (EUMDR) is challenging medical device companies globally.
EUMDR creates new regulatory expectations with the device reporting regs four times longer than previously. These changes result in increased costs and complexity of doing business in the EU. This benchmark study probes the real-world costs and challenges that companies are experiencing during this transition from Medical Device Directive(MDD)/Active Implantable Medical Devices to new requirements in Medical Device Reporting (MDR).
This study examines the cost impact the new regs will have on companies with large vs. small EU revenues and on the product's therapeutic area/condition. The study also looks at costs across implementation activities.
This study provides segment perspectives based on company's EU revenues, company size and product risk.
Best Practices, LLC engaged executives from 25 Medical Device and technology companies across 15 therapeutic areas.
Medical Device; Technology; Pharmaceutical; Health Care; Science; Manufacturing; Research; Diagnostic
Becton Dickinson; RaySearch Laboratories; Medtronic; Zap; Teleflex; SinuSys; Cardinal Health; Atos; Boston Scientific; Rhythmlink; Thermo Fisher; Celo Nova; ConMed Corporation; Kestra; Zimmer Biomet; Xodus Medical; 3M Company; Establishment Labs; inStem; Aqualizer; Avanos Medical; Ascensia; Needle Tech Products; Dentsply Sirona; Foundation Medicine
If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.