iAuditor (Consulting for Medical Devices)

iAuditor is a specialized consultancy firm based in Poland that focuses on the medical device industry. The company provides expertise, training, certification support, and implementation services for regulatory affairs and quality standards required for medical devices in the European Union, the United States, and Canada. The firm operates as a boutique consultancy led by Romuald Urbański, leveraging his extensive background as a lead auditor and regulatory manager. It serves as a resource for manufacturers navigating complex compliance landscapes, offering both free and subscription-based knowledge databases for industry professionals.