My name is Rob Udo. Since founding Udo Consultancy in 2003, I’ve been supporting manufacturers and their suppliers in the medical device industry in complying with applicable standards and European regulations. I believe a quality management system only adds value if it is practical and tailored to the organisation—the system should work for the organisation, not the other way around.

 

With over 30 years of experience as a senior advisor, trainer, and contract auditor, I assist companies with:

I have been an IRCA-certified QMS Lead auditor since 1998 and work as a (contract/external) Lead Auditor for DEKRA Certification BV (formerly KEMA), conducting audits for ISO 13485 and MDR. I also train new DEKRA auditors on audit techniques and the interpretation of regulatory requirements.

 

My background is in mechanical engineering (I and II), and since entering the medical device sector in 1991, I’ve gained hands-on experience in:

I’ve worked on various products, including ultrasound catheters, wound dressings, dental implants, patient warming systems, endoscopes, electrostimulation devices, and diabetes-related products.

 

When needed, I collaborate with trusted partners to provide the right expertise. My commitment to delivering high-quality, practical, and value-driven services is reflected in the long-term relationships and referrals I receive from satisfied clients.

 

Interested in working together? I’d be happy to hear from you.