Results for

Expert reports

2 Companies

5 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
HEMPARTIS GMBH

Germany

Hempartis GmbH is a family-managed company and stands for research, production and sales of hemp extracts, cannabinoids, food supplements and cosmetics. Here you encounter specialists in the development and production of innovative products. Our team supports you from your idea to the finished product. Whatever you want, whether a cream, spray, oil, capsules, jelly babies, chewing gum, lollipops, beverages or other specialities – we look forward to your ideas. Hempartis technical equipment includes units for extraction, distillation, micellisation, analysis, product manufacture, filling and packaging. Liposomal formulation of functional ingredients is also one of our technical strengths. Our mode of operation and production are certified according to the highest standards (ISO 9001, ISO 22000, GMP ISO 22716, COSMOS standard, HACCP, ORGANIC, kosher, halal). Quality at the highest level on fair terms is waiting for you. As a partner for product developments and contract manufacturing, we offer: Development and production of food supplements and cosmetic products. Creation of safety reports and PIDs. Contract filling, packaging. Production and sale of hemp extracts, distillates, CBD flowers, CBD oils and isolated cannabinoids. Training and consultation. Networking with first-class expert associations in the areas of analysis, law and certifications expands the range of services.

Find quotes for

Filters

Results for

Expert reports

Number of results

2 Companies