About
My name is Rob Udo, and I help medical device manufacturers and their suppliers to comply 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 am 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 and gained practical experience in design and development, manufacturing, quality, and regulatory affairs, including process validation, cleanroom design and validation, biocompatibility testing, and sterilization processes. Since then, products I have worked on include, among others, 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.
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 am 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 and gained practical experience in design and development, manufacturing, quality, and regulatory affairs, including process validation, cleanroom design and validation, biocompatibility testing, and sterilization processes. Since then, products I have worked on include, among others, 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 add value to your organization. Your management system should fit your organization. Your management system should work for you and not the other way around.
I work as a contract auditor for Notified Bodies for the ISO 13485, MDD, MDR, MDSAP, the Taiwanese program, and ISO 9001. Consulting and auditing activities are strictly separated and never conducted for the same manufacturer, product, or related file. I provide training on the ISO 13485 requirements and auditing techniques to new notified body auditors.
I work as a contract auditor for Notified Bodies for the ISO 13485, MDD, MDR, MDSAP, the Taiwanese program, and ISO 9001. Consulting and auditing activities are strictly separated and never conducted for the same manufacturer, product, or related file. I provide training on the ISO 13485 requirements and auditing techniques to new notified body auditors.
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 reflected in the numerous referrals from existing customers, which ensure the continuous growth of my business.
Feel free to contact me for a free inquiry.
Rob Udo
Udo Consultancy
Udo Consultancy