UDO CONSULTANCY - Key Persons
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 25 years of experience in ISO13485, ISO14971, EU MDD (93/42/EC), EU MDR (2017/745), Canadian MDR, Japanese Ordinance 169, Taiwanese requirements, and ISO9001. This experience has been gained 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 the areas of design and development, manufacturing, quality, and regulatory affairs, including process validations, cleanroom design and validation, biocompatibility testing, and sterilization processes. Products I have worked on since then include, among others, ultrasound imaging catheters, wound dressings, dental implants, various software applications classified as a medical device, 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.
I work as a contractor for DEKRA Certification BV (formerly KEMA) as a Notified Body Lead Auditor for the MDD/MDR as well as Lead Auditor for ISO 9001 and 13485. In addition, I'm qualified for the Taiwanese GMP, and MDSAP (Medical Device Single Audit Program) as of 2018. I provide training on the ISO 13485 requirements and auditing techniques to new DEKRA auditors.