Results for

Technical assessment - Service Provider - Germany

3 Companies

4 Products

TECHNISCHE DOKUMENTATION - KARLA FLEMMING

Germany

Erstellung von gesetzeskonformen verständlichen Betriebsanleitungen für Maschinen, Maschinenteile und Konsumgüter zur Erlangung der CE-Konformität. Technische Dokumentation - Karla Flemming | Ingenieurbüro - Technische Redaktion, ist Ihr starker Partner wenn es darum geht Bedienungsanleitungen, Instandsetzungsanleitungen, Wartungsanleitungen, Softwareanleitungen, Kurzanleitungen, Firmenbroschüren, Ersatzteilkataloge, Produktdatenblätter, Sicherheitsdatenblätter, Betriebsanweisungen u.a., unter Beachtung der Risikobeurteilung zu erstellen. Dann sollte das Ausstellen der Konformitätserklärung für Ihre Maschine oder Produkt kein Problem mehr sein. Wenn Sie technische Anleitungen benötigen, kontaktieren Sie mich bitte. Sehr gerne erstelle ich Ihnen eine Angebot nach Rücksprache üben den Auftragsumfang. Als Zertifizierte Technische Redakteurin und Dipl.-Ing. (FH) Maschinenbau und jahrelanger Erfahrung in den Bereichen Dokumentation und Technik, bin ich ein adäquater Partner in Sachen Technischer Dokumentation.

All the products for "technical assessment"

Technical Documentation, Conformity and Risk Assessment

Technical Documentation, Conformity and Risk Assessment

See all 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

All the products for "technical assessment"

MDR Technical Documentation

See all products
ESIS GMBH

Germany

ESIS GmbH have long experience in rendering service in technical areas, NPP commissioning and operation, quality assurance, conformity assessment, safety analyze, design, licensing and also in the field of NPP Personnel Training. They were participants of international projects on NPP safety enhancement and creation of NNEGC Energoatom normative documentation, NNEGC Energoatom Personnel Training System creation and upgrading, creation of Product Conformity Assessment System of Energoatom, etc. The most part of specialists of ESIS GmbH have long experience in NPP operation (former Ukrainian NPPs employers). ESIS key experts earlier worked in NNEGC Energoatom, Ukrainian NPP Personnel Training and Licensing Department. They are the authors and participants of development of all standards of Energoatom and the Ministry of Fuel and Energy in the sphere of NPP personnel training.

Find quotes for

Filters

Results for

Technical assessment - Service Provider - Germany

Number of results

3 Companies