Hire the Best Technical Documentation Writers in Berlin, DE

More than 18 years of experience in the Medical Device and IVD Industry, mainly in Medical Affairs, Regulatory Affairs and also in Quality Management, in the fields of surgical ophthalmology, dermatology, gynecology, medical imaging, orthopedic surgery and oncology. Focused primarily on Clinical Evaluation for Medical Devices / Performance Evaluation for IVDs, along with writing other types of documentation associated with the CER / PER. Experienced in conducting Literature Reviews / Clinical Evaluations / Performance Evaluations for medical devices and IVDs of all classes. Other major projects include strategic planning for the transition from MDD to EU MDR, process validation, audit readiness (ISO 13485, 21CFR820, and EU MDR), and Notified Body deficiency resolution.

I specialize in project management and R&D, with a focus on robotics, medtech, hardware, custom electronics and firmware. I manage the full product lifecycle - from concept and design to prototyping, testing, and production - delivering integrated solutions that bridge hardware, software and mechanical engineering. I am a seasoned professional with extensive experience in hi-tech business development, project management and the development of robotics and automation systems that optimize operations across multiple industries, including special purpose robotics. In addition to technical expertise, I bring solid business development experience in the same fields, as well as deep knowledge of franchising models, product and franchise creation, and sales/network expansion. Core competencies R&D leadership: Managing the full development cycle for automation solutions, including medical devices, mechatronics, embedded systems, full-stack hardware development, and full-stack software development. Proven ability to take custom robotic and automation solutions from concept to market success. Skilled in analyzing, researching, designing, and producing bespoke solutions for manufacturing, intralogistics, last-mile delivery, and medical devices. Expertise in educational franchise creation, strategic marketing, network development, and sales. End-to-end mechatronics development, from ideation to prototyping and production (R&D management, Team Lead, Tech Lead, Project manager). Comprehensive product development - market research, customer interviews, product-market fit validation, technical documentation, user manuals. Service offerings: + End-to-End project management, from initial concept and design to implementation and ongoing support, ensuring smooth project delivery. + Custom solution development in a full-fledged R&D Lab (Berlin). Capable of small-scale batch production and full documentation for seamless transition from prototype to mass production. + Robotics and automation consulting, expert guidance to enhance efficiency and productivity in fulfillment, intralogistics, and other automation domains. Achievements: + Successfully developed and deployed autonomous mobile robots for indoor and outdoor applications using advanced technologies. + Delivered high-quality, reliable automation solutions for modern logistics and manufacturing environments. + Consistently achieved high client satisfaction through tailored solutions and dedicated support in biomedical and edtech product development. Why work with me + Tailored automation solutions aligned with your specific business needs. + Proven track record in delivering complex robotics and automation projects. + Full-spectrum support from initial consultation to ongoing maintenance for long-term success. If you need a partner who can manage R&D in robotics, develop custom electronics and firmware, or optimize logistics processes with smart automation, I am here to help.