The works technical - Import export

Memcell classic The MEMCELL plant has been developed to run laboratory trial with minimized effort. The plant is suitable for membrane screening, cleaning examinations, lab trials and quality management. All common flat sheet membranes can be used. The plant is suitable for the following processes: Ultrafiltration Nanofiltration Reverse osmosis The flat module corresponds in his hydraulic properties to a spiral wound element. So, examinations with the flat module can be used for up-scaling to pilot plant sizes. The flat cell is available with various spacers (30-44-80mil); to run the plant with another spacer, only the middle part of the test cell has to be changed. On permeate side, there is a porous sinter plate to guarantee a steady permeate flow. So, a reliable scale-up is possible. For membrane manufacturer or technical institutes, the MemCell is available on request with parallel or seriell connection of more than one test cell. Technical data: Working pressure 64 bar (standard)

Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:
 Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities