SAHIROUN (PVT) LTD.

mdi Consultants, Inc. is a regulatory compliance consulting firm with 45 years of experience serving the medical device, pharmaceutical, biotechnology, and food industries. The company specializes in FDA regulatory submissions, including 510(k) applications, PMA/PDP preparation, and establishment registration. Services extend to international markets, offering CE marking guidance, Health Canada regulatory consulting, ISO 13485 implementation, and cybersecurity validation (ISO 27001 / FD&C Act Section 524B compliance). The firm provides US Agent designation services for foreign manufacturers and maintains a 100% first-time success rate for ISO certification. With over 500 client engagements since 1978 and a track record of more than 1,800 successful 510(k) submissions, mdi Consultants delivers fixed-price consulting with performance guarantees.