Documentation- technical - Import export

Karla Flemming CE-Koordinatorin und Expertin für Technische Dokumentation Ingenieurbüro für Technische Dokumentation - Karla Flemming

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

Special features of the Lipp welding technology are the automated on site construction of above the ground cylindrical tanks made of various grades of duplex steel, stainless steel and black steel. Moreover, the technology also incorporates the post treatment of the weld and a visualized welding monitoring and the technical documentation of the process. Due to the flexible and mobile concept of the equipment, the installation can either be done on greenfield construction sites but also inside buildings or in places with limited access and working space.

Anyone can take something apart. Dismantling is a job for the professionals. Correctly dismantling equipment at the old location is the first step in moving machinery and relocating production. Our experts know how to handle your sensitive equipment. This is why dismantling for us means more than just taking the system and all its components apart and properly disconnecting the utilities. It also includes scrupulously matchmarking and documenting, technical cleaning and carefully packing each and every part. You can be sure that everything is ideally prepared for safe transport and subsequent reassembly. When a machine has reached the end of its life cycle, SCHOLPP can also take care of disposals on any scale. We take all the necessary safety precautions and ensure that the proper disposal of materials is fully documented. Carefully dismantling complex machinery and systems is a job for experienced professionals.

TECHNOLOGICAL INNOVATION OPENING UP NEW MARKETS The new automated Lipp welding process will again shake up tank construction market just as the well established Lipp double fold system did decades ago. It is a perfect combination of the long experience in metal forming and state of the art welding technology. KEY BENEFITS OF THE LIPP WELDING TECHNOLOGY Automated welding proces, on site Visual weld monitoring and technical documentation Reinforcement ribs for enhanced structural stability and reduced material costs High quality and repeatability Fast installation Choice of different material grades and types CERTIFICATES SPECIFICATIONS OF THE LIPP WELDING TECHNOLOGY BLACK STEEL SPECIFICATIONS OF THE LIPP WELDING TECHNOLOGY STAINLESS STEEL Beside black steel, various grades of stainless steel and duplex steel can be auto welded. In addition to the new potential markets and applications, the Lipp automated welding technology will increase the competitiveness

Welcome to the engineering office for technical documentation - Karla Flemming, your trustworthy partner for technical documentation and conformity assessment. As an experienced mechanical engineer and technical writer, I offer you comprehensive services in the area of technical communication and product safety. Our expertise: 1. Technical documentation: With a deep understanding of complex technical systems and years of experience in technical writing, we create precise, well-structured and easy-to-understand technical documentation. From instruction manuals to operating instructions to service manuals, we deliver high-quality content that your customers will value. 2. Conformity assessment: We support you in ensuring that your products comply with applicable national and international standards. Through our thorough compliance assessments, we help you obtain all the necessary certifications and meet market requirements. Best regards, Karla Flemming Owner