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.
Its predominant role is that of “authorized representative”; a prerequisite for all non-European manufacturers without a subsidiary / place of business within the European Union. Services include labeling review, product registration, post market surveillance, product classification, vigilance, language requirements and general guidance in interpreting the Directives 90/385/EEC, 93/42/EEC & 98/79/EEC.
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 (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.