regulatory and quality system professionals | 919.313.3960

Circle of Influence

Providing the best care for our clients means partnering with businesses that extend our quality and regulatory experience and scope of services. These are businesses we trust to deliver the same level of value, service and skill to our clients as we do.

MDI Europa

mdi Europa GmbH was founded in March 2000 to provide medical device manufacturers world-wide with flexible and well-adjusted service packages to assist clients to comply with EU legislation.

mdi Europa GmbH acts as European Authorized Representative as defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the (Active Implantable) Medical Devices Directive 90/385/EEC and 93/42/EEC (AIMDD and MDD) and the In Vitro-Diagnostic Medical Devices Directive 98/79/EC (IVDD) for a wide range of companies – from start-ups to established corporations throughout the world. Our highly qualified regulatory affairs specialists provide hands-on experience and have registered hundreds of medical device manufacturers for CE Marking with the European competent authorities.

Klass Consulting

Klaas Consulting is a Sales and Marketing Consultancy, dedicated to assisting global acting medical devices companies in entering all European markets, Turkey and Russia. Their main service is finding and managing distributors. In addition they focus on reimbursement and global marketing strategies and operations.

Medical Equipment Compliance Association, LLC

Medical Equipment Evaluation, Testing, Compliance Reports for the FDA, Health Canada, Notified Bodies (for CE Marking, under the MDD), as well as other International Agencies.

Strategic Compliance International, Inc.

Strategic Compliance International, Inc (SCI) provides support building and maintaining worldwide regulatory compliance for a wide range of regulatory compliance and quality assurance challenges for biologics, medical devices and drug companies.