Results for

Project planning

4 Companies

70 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

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TIS INDUSTRIESERVICE

Germany

With over 20 years' experience we make a significant contribution to the business success of our industrial customers. Almost all fields of industry rely on our performance and profit from our customised service – in terms of quality and flexibility, as well as costs. Thanks to our expertise, we are also able to produce large orders in an agreed time-frame (e.g. complete plant relocation to Turkey over a 5-month period). Excellent international contacts also ensure that your operations are run smoothly and processed in line with legal requirements. Machine assembly/plant assembly, shelf testing in accordance with DIN EN 15635; Specialist in the testing of pallet racking, disassembly/re-assembly, machine relocation/production relocation, assembly/disassembly of KBK crane installations, planning/project management, maintenance/repair, industrial cleaning, building cleaning, facility management (specialist in accordance with WHG)
BLOCHER PARTNERS

Germany

A renowned Germany-based architecture and design firm blocher partners. Our diverse team of architects, graphic designers, interior designers, communication specialists, environmental planners and product designers is spread accross Stuttgart, Berlin, Mannheim and Ahmedabad. For all our projects, we combine architecture, urban planning, interior design, product design and communication and into a whole.Our strength is our expertise in different disciplines such as commercial, residential, hospitality, mixed-use and high-rise buildings. The concept of ’experiential design’ lies at the core of our interdisciplinary approach, always placing the end user at the center.Our building approach is a modest and measured one, choosing what is suitable rather than sensational, creating buildings that speak for themselves and are self-aware. We combine technologically advanced concepts with a clear design vocabulary, creating buildings that are stable long-term investments. Backed by such solid principles, this approach helps open doors to new and exciting solutions.A sustainable and lasting building design requires economic and social responsibility. Buildings that are loved also last longer. This is why we always create spaces, whether they be public or private, commercial spaces or even brands, which touch, inspire, and encourage interactions.We continuously adapt to new places and cultures, seeking one-on-one dialogue with all involved stakeh
ARCHITEKTIN KELBING

Germany

Architektin Kelbing has been practicing architecture and design since 2003, having worked on many leading private and public projects in Überlingen and the wider Lake Constance/Bodensee region of Baden-Württemberg in Southern Germany. This includes a range of project sizes and types, including residential buildings, urban design/planning and regeneration, commercial, industrial, and landmark sites for the public sector. Comprehensive services cover: pre-design planning, analysis and advisory; architecture and interior conceptual design lead and project management; as well as construction administration. Taking a responsive and collaborative approach, working closely with the customer to better understand their lifestyle, work, interests, ideals, and what makes them most comfortable. At the same time, however, an understanding of the unique space and time, environment, an appreciation for traditions, styles and new trends is also required.

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4 Companies