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Clinical analysis

2 Companies

1 Product

MAXCERT LTD

Germany

Maxcert can provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the MDR certification process. QMS / Risk Management - Strategy for Regulatory Compliance - MDR-Specific QMS Changes - Classification & Conformity Assessment - Other EU MDR Directives & Regulations - Risk Management Evaluation Criteria - Benefit Risk Analysis - MDR Readiness Audits Clinical Evidence - Guidance on New Clinical Evidence Requirements - Legacy Product Data Review - Performance Evaluation Plan / Report (PEP/PER) - Analytical Performance Report - Clinical Performance Plan / Report - Clinical Performance Study Plan (CPSP) - Scientific Validity Report Labelling & UDI - Intended Purpose / Claim Review - Labels & Instructions for Use Requirements - Applicable Standards - UDI Requirements & Symbols Technical Documentation - Technical Documentation Review & Preparation - GSPR Gap Assessments & Traceability Matrices - Test, Hardware, Software Requirements Post-Market Surveillance / Vigilance - Post-Market Surveillance Plan / Report - Post-Market Follow-up (PMPF) Plan / Report - Incident Reporting - Periodic Safety Update Report (PSUR) Economic Operators / EUDAMED - Person Responsible for Regulatory Compliance (PRRC) - Registration of EO’s & Devices - Control of Suppliers (Process/Method) To speak to an MDR expert, or if you don’t see the services you are looking for, contact us

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MDR Technical Documentation

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DERMAL FILLER GLOBAL TRADING

Germany

Welcome to dermalfillerglobaltrading.com, a reliable and convenient way for Clinics, Medical Professionals and Wholesalers to purchase Dermal Fillers, Orthopaedics & all other Medical Devices from one trusted source at a competitive price. Dermal Filler Global Trading & Authentic fillers shop to stock up on advanced materials . You need someone you can trust when it comes to delivering 100 % legitimate , absolutely Botulinums Toxin & authentic filler and with us you can be absolutely certain in this regard . Our dedication to quality and scientific integrity has made us one of the most respected suppliers in the online market , a reputation We take very seriously and work hard to maintain . We offer our customers both most demanded as well as rare Dermal Filler Global Trading and authentic fillers . Every new batch of product passes laboratory tests and arrives to us Complete with certification of analysis , this way We always know that we supply our customers with exceptionally Botulinums Toxin and authentic fillers . Through our efforts , we supply the highest quality with most competitive price . Consistent quality , rich experience in exporting , low risk , prompt service and short lead tỉme , all these advantages are winning more and more customers and high market share for us . More over , Most will fill hollows, lines, and wrinkles in less than 30 minutes with results that can last from 4 months to more than a year., Browse our extensive range of fillers to smooth out f

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