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EU MDD and Canadian MDR Requirements * Medical Device Clinical Studies and Performance Testing * Regulatory Insight
Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.
Comprehensive worlwide regulatory consulting services.
In Europe, clinical studies are regulated by the Medical Device Directive (Council Directive 93/42/EEC),
as amended by DIRECTIVE 2007/47/EC.
In Canada, clinical studies are regulated by the Medical Devices Regulations (SOR/98-282).
Regulatory Insight has experience in establishing human clinical studies in these regions and can assist your company to run your studies
in Europe and Canada, including attaining European Ethics Committee approval (for studies run in Europe)
and Canadian Research Ethics Board approval (for studies run in Canada).
FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions
FDA Registration Consultants | FDA Compliance Consultants | FDA Submissions | FDA Compliance | Medical Device Consulting | Training | Imports/Exports | Contact
