Regulatory Affairs Consulting |

Strategic planning
Project Management
US Regulatory submissions to FDA (export approvals, pre-IDEs, IDEs, 510(k)s and PMAs for all classes of medical devices)
FDA meetings (introductions of company and device, regulatory & clinical strategies, test plans)
ISO Certification and CE Marking (OUS Regulatory submissions include Technical Files, Design Dossiers, Clinical Evaluation Reports)
Notified Body meetings (interviews/hiring/contracts)
Regulatory input on test requirements/plans, external standards, essential requirements, predicate device comparisons
Internal audits, including GLP animal lab audits
Mock FDA and Notified Body Audits
On-site Regulatory support during FDA and Notified Body inspections
Management of product recalls, safety alerts, market withdrawals
Decision making on reportable changes to regulatory agencies
Daily operational regulatory guidance and support (Acting Regulatory VP role for companies)
Animal study design and scribe during studies
Regulatory representative in due diligence discussions for acquisitions and mergers
Design, Development and Implementation of Quality Management System (Quality System Regulation and ISO 13485)
Development, implementation and maintenance of Document Control Systems
ISO Certification and CE Marking
Quality System training
Internal audits and audit program implementation
Design History Files
Management Representative
Notified Body and FDA Liaison
Facility Registration and Device Listing
Review of labeling and advertising materials

Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.

Regulatory Affairs Consulting