Results for

Report on product safety - Service Provider - Germany

2 Companies

4 Products

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

See all products
GEBRÜDER BURGER GMBH & CO KG PRÄGEFOLIENFABRIK

Germany

Gebrüder Burger GmbH & Co KG is aware of its social responsibility and meets the standards of international codes of conduct. Our corporate activity is based on applicable legal and ethical standards, with a particular emphasis on the well-being of our employees. In addition, we strive to protect the environment. The operation of our systems is inspected in line with legal provisions. We only use raw materials which are pre-registered or have already been registered. The same applies for our foils from sites outside the European Union. The foils themselves are classed as products in line with EU Regulation 1907/2006 dated 18th December 2006 and are not subject to mandatory registration. Our foils are primarily produced in Germany. For foils produced outside of Germany, we take care to ensure the same high standard of quality for raw materials and manufacturers.

Website

Find quotes for

Filters

Results for

Report on product safety - Service Provider - Germany

Number of results

2 Companies