We (Maven Profcon Services LLP) are a consulting organization specializing in Medical Devices. We have been in this field for the past eight years, working with more than 300 prestigious organizations with exposure to various medical devices. We also cater to more than 50% of certified or in-process Orthopedic Implant manufacturers in India. Our expertise includes full fledged Consultation & Training for EU MDR (CE Marking), US FDA 510k, UKCA, MDSAP, ISO 13485, Consultancy as per customer needs such as Clinical Evaluation Report (CER), Risk Management (RMF), Post Marketing activities (PMS, PSUR, PMCF). We also assist and provide services for Free Sales Certificate (FSC), Country Registrations, European Representative (EAR), and US Agent.
Industry
Business Consulting and Services, Other Business Services, Business Services, Certification services for food safety, Research and testing, IT, Internet, R&D, Product certification services, Mailing lists, Business-to-Business (B2B), Services to businesses, Business management consultants
HQ Location
1215 & 1216, Iconic Shyamal
Shyamal Cross Road
Ahmedabad, Gujarat 380015, IN
Keywords
Medical DeviceCE MarkingISO 13485:2016US FDANIOSHEU MDRUKCA510kTraining on Regulatory topicsCER