UDO Consultancy supports medical device manufacturers and their suppliers in complying with the applicable standards and EU regulations for medical devices. I'm a senior consultant and trainer with over 30 years of experience in ISO 13485, ISO 14971, EU MDD (93/42/EC), EU MDR (2017/745), MDSAP, Taiwanese requirements, and ISO 9001. I gained this experience in various quality management positions within the Medical Device Industry. I have been a qualified QMS auditor since 1998, registered with the IRCA (International Register Of Certificated Auditors).I have a background in mechanical engineering I and II. After graduating, I started my career in the medical device industry in 1991. I gained practical experience in design and development, manufacturing, quality, and regulatory affairs, including process validations, cleanroom design and validation, biocompatibility testing, and sterilization processes. Since then, I have worked on products such as ultrasound imaging catheters, wound dressings, dental implants, various software applications classified as medical devices, patient warming devices, endoscopes, devices for electrostimulation, and diabetic care products. I founded Udo Consultancy in 2003 to support my private clients in the medical device industry.My vision is that a management system should have added value for your organization. Your management system should fit your organization. Your management system should work for you and not the other way around.Udo Consultancy offers the following services. ✔️Consultancy✔️Audits✔️Training✔️Interim managementI work as a contractor for DEKRA Certification BV as a Notified Body Lead Auditor for ISO 13485, MDD, MDR, MDSAP, the Taiwanese program, and ISO 9001. I provide training on the ISO 13485 requirements and auditing techniques to new DEKRA Certification BV auditors.As of June 2021, I have been appointed officially as a freelance trainer for Mikrocentrum for medical device-related training. As required, I work with multiple partners to provide specific knowledge and expertise to my clients.My dedication to providing high-quality services to my clients is paid off by the numerous referrals from existing customers that ensure the continuous growth of my business. Feel free to contact me for a free inquiry. Rob UdoUdo Consultancy
Listed skills include Iso 13485, Quality Management, Quality System, Medical Devices, and 19 others.
