Regulatory Affairs Services Expert regulatory strategy and submission support for FDA, EU, and global markets. Our Regulatory Affairs Services Every RA Service listed below in the Client’s Product lifecycle is performed to agreed on Requirements & Scope, and assures all applicable Regulatory requirements are met at each stage. D&D: → QA: → Our Regulatory Management Our Specialists can provide Expert, Advanced or Competent level Skill as required by the Client, in the following. EU Authorized Representative Manufacturers outside the EU must designate an EU Authorized Representative under the EU MDR (Regulation (EU) 2017/745, Art. 11). We act as your legal presence in the EU. Learn more about our EU Authorized Rep Service Achieve Regulatory Approval Client Prospects CLICK to get Started! OR CLICK to Learn more of our Industries! Sales Affiliates CLICK to Contact Us! · Regulatory Strategy · Requirements & Specifications · Quality Planning · Product Classification: US, EU, Canada · Regulatory Pathway: 510(k), De Novo, PMA, CE Mark · Applicable Standards & Regulations, into the Specifications · Regulatory Assessment · Concept & Prototyping · Design Controls · Regulatory & Competitive Analysis (EU MDD / MDR, US 510(k) / De Novo) · Predicate Device Identification · Pre-Submission Meetings · Conformity & Clinical Evidence · Verification & Validation · V&V & Process Validation · Conformity to Recognized Standards · Clinical Evaluation, by Literature & Study Route · IDE & Clinical Investigation Support · Safety & Performance Compliance · Risk & Reliability Engineering · Risk Management File · Risk Management to ISO 14971, for FDA & EU MDR · EU MDR General Safety & Performance Requirements · Submissions & Market Authorization · Manufacturing Transfer & Supply Chain · Supplier Quality & Production Controls · US 510(k), De Novo & PMA Submissions · EU Technical Documentation & CE Marking · Health Canada Licensing (MDSAP) · Establishment Registration & State Licensure · Post-Market Compliance · Reporting & Design Controls · Post-Market & Records · Post-Market Surveillance & Vigilance · Notified Body & Competent Authority Interaction · FDA Inspections (QMSR, cGMP) · Regulatory Impact of Design Changes · Regulatory Submissions · US FD&C Act: 510(k), De Novo, Custom, IDE, PMA & Orphan · EU CE Mark: Medical Device including IVD, Cosmetic & OTC Pharmaceutical · MDSAP: United States, Canada & Australia · Jurisdictions & Regulations · United States: FD&C Act, QMSR (21 CFR 820), cGMP · OTC Pharmaceutical: 21 CFR 210 & 211, Monographs · European Union: MDD & MDR, CE Marking, EU Authorized Representative · Canada: Medical Devices Regulations (SOR/98-282) · MDSAP: US, Canada, Australia, Brazil & Japan · Product Classes · US: Class I, II & III · EU: Class I, Is, IIa, IIb & III · Canada: Class I, II, III & IV · OTC Pharmaceutical · Inspections & Audits · FDA Inspections · Notified Body Audits · Competent Authority & Third-party Approvers